Accessory devices of an ostomy system, and related methods for communicating leakage state

ABSTRACT

The present disclosure provides a method, performed in an accessory device, for communicating a leakage state of an ostomy appliance, wherein the accessory device comprises an interface configured to communicate with one or more devices of an ostomy system, the one or more devices comprising a monitor device, and/or the ostomy appliance configured to be placed on a skin surface of a user. The method comprises obtaining monitor data from the one or more devices, the monitor data being indicative of presence of fluid at a proximal side of a first adhesive layer of the ostomy appliance towards the skin surface; determining a leakage state at the proximal side of the first adhesive layer of the ostomy appliance based on the monitor data, and communicating the leakage state of the ostomy appliance via the interface.

The present disclosure relates to an accessory device of an ostomysystem and related methods for monitoring an ostomy appliance. Theostomy appliance system comprises an ostomy appliance, an accessorydevice and a monitor device. In particular, the present disclosurerelates to methods for communicating the leakage state of the ostomyappliance.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings are included to provide a furtherunderstanding of embodiments and are incorporated into and a part ofthis specification. The drawings illustrate embodiments and togetherwith the description serve to explain principles of embodiments. Otherembodiments and many of the intended advantages of embodiments will bereadily appreciated as they become better understood by reference to thefollowing detailed description. The elements of the drawings are notnecessarily to scale relative to each other. Like reference numeralsdesignate corresponding similar parts.

FIG. 1 illustrates an exemplary ostomy system,

FIG. 2 illustrates an exemplary monitor device of the ostomy system,

FIG. 3 is an exploded view of a base plate of an ostomy appliance,

FIG. 4 is an exploded view of an exemplary electrode assembly,

FIG. 5 is a proximal view of parts of a base plate,

FIG. 6 is a distal view of an exemplary electrode configuration,

FIG. 7 is a distal view of an exemplary masking element,

FIG. 8 is a distal view of an exemplary first adhesive layer,

FIG. 9 is a proximal view of the first adhesive layer of FIG. 8,

FIG. 10 is a distal view of a part of the base plate including monitorinterface,

FIG. 11 illustrates an exemplary method of communicating the leakagestate according to the present disclosure,

FIG. 12 illustrates an exemplary accessory device according to thepresent disclosure,

FIGS. 13a-c illustrate exemplary user interfaces for communicating theleakage state according to the present disclosure.

DETAILED DESCRIPTION

Various exemplary embodiments and details are described hereinafter,with reference to the figures when relevant. It should be noted that thefigures may or may not be drawn to scale and that elements of similarstructures or functions are represented by like reference numeralsthroughout the figures. It should also be noted that the figures areonly intended to facilitate the description of the embodiments. They arenot intended as an exhaustive description of the invention or as alimitation on the scope of the invention. In addition, an illustratedembodiment needs not have all the aspects or advantages shown. An aspector an advantage described in conjunction with a particular embodiment isnot necessarily limited to that embodiment and can be practiced in anyother embodiments even if not so illustrated, or if not so explicitlydescribed.

Throughout this disclosure, the words “stoma” and “ostomy” are used todenote a surgically created opening bypassing the intestines or urinarytract system of a person. The words are used interchangeably, and nodifferentiated meaning is intended. The same applies for any words orphrases derived from these, e.g. “stomal”, “ostomies” etc. Also, thesolid and liquid wastes emanating from the stoma may be referred to asboth stomal “output,” “waste(s),” and “fluids” interchangeably. Asubject having undergone ostomy surgery may be referred to as “ostomist”or “ostomate”—moreover, also as “patient” or “user”. However, in somecases “user” may also relate or refer to a health care professional(HCP), such as a surgeon or an ostomy care nurse or others. In thosecases, it will either be explicitly stated, or be implicit from thecontext that the “user” is not the “patient” him- or herself.

In the following, whenever referring to proximal side or surface of alayer, an element, a device or part of a device, the referral is to theskin-facing side or surface, when a user wears the ostomy appliance.Likewise, whenever referring to the distal side or surface of a layer,an element, a device or part of a device, the referral is to the side orsurface facing away from the skin, when a user wears the ostomyappliance. In other words, the proximal side or surface is the side orsurface closest to the user, when the appliance is fitted on a user andthe distal side is the opposite side or surface—the side or surfacefurthest away from the user in use.

The axial direction is defined as the direction of the stoma, when auser wears the appliance. Thus, the axial direction is generallyperpendicular to the skin or abdominal surface of the user.

The radial direction is defined as perpendicular to the axial direction.In some sentences, the words “inner” and “outer” may be used. Thesequalifiers should generally be perceived with respect to the radialdirection, such that a reference to an “outer” element means that theelement is farther away from a centre portion of the ostomy appliancethan an element referenced as “inner”. In addition, “innermost” shouldbe interpreted as the portion of a component forming a centre of thecomponent and/or being adjacent to the centre of the component. Inanalogy, “outermost” should be interpreted as a portion of a componentforming an outer edge or outer contour of a component and/or beingadjacent to that outer edge or outer contour.

The use of the word “substantially” as a qualifier to certain featuresor effects in this disclosure is intended to simply mean that anydeviations are within tolerances that would normally be expected by theskilled person in the relevant field.

The use of the word “generally” as a qualifier to certain features oreffects in this disclosure is intended to simply mean—for a structuralfeature: that a majority or major portion of such feature exhibits thecharacteristic in question, and—for a functional feature or an effect:that a majority of outcomes involving the characteristic provide theeffect, but that exceptionally outcomes do no provide the effect.

The present disclosure relates to an ostomy system and devices thereof,such as an ostomy appliance, a base plate for an ostomy appliance, amonitor device, and optionally one or more accessory devices. Further,methods related to an accessory device of the ostomy system andaccessory devices thereof are disclosed. An accessory device (alsoreferred to as an external device) may be a mobile phone or otherhandheld device. An accessory device may be a personal electronicdevice, e.g. a wearable, such as a watch or other wrist-worn electronicdevice. The ostomy system may comprise a docking station. An accessorydevice may be a docking station. An accessory device may act as adocking station. The docking station may be configured to electricallyand/or mechanically couple the monitor device to the docking station.The docking station may be configured for charging the monitor deviceand/or configured for transferring data between the monitor device andthe docking station, and/or between the accessory device and the dockingstation and/or between the monitor device and the accessory device viathe docking station. The ostomy system may comprise a server device. Theserver device may be operated and/or controlled by the ostomy appliancemanufacturer and/or a service centre.

The present disclosure provides an ostomy system and devices thereof,such as an ostomy appliance, a base plate for an ostomy appliance, amonitor device, and optionally one or more accessory devices whicheither alone or together facilitate reliable determination of thenature, severity and rapidness of moisture propagation in the adhesivematerial provided for attaching the base plate to the skin surface of auser. Depending on the nature of the pattern of moisture propagation inthe adhesive material, the ostomy system and devices thereof enableproviding information to the user about the type of failure, and in turnenable providing an indication to the user of the severity and thus theremaining time frame for replacing the ostomy appliance withoutexperiencing severe leakage and/or skin damage.

The ostomy appliance comprises a base plate and an ostomy pouch (alsoreferred to as an ostomy bag). The ostomy appliance may be a colostomyappliance, an ileostomy appliance or a urostomy appliance. The ostomyappliance may be a two-part ostomy appliance, i.e. the base plate andthe ostomy pouch may be releasably coupled e.g. with a mechanical and/oran adhesive coupling, e.g. to allow that a plurality of ostomy pouchescan be utilized (exchanged) with one base plate. Further, a two-partostomy appliance may facilitate correct application of the base plate toskin, e.g. to an improved user sight of the stomal region. The ostomyappliance may be a one-part ostomy appliance, i.e. the base plate andthe ostomy pouch may be fixedly attached to each other. The base plateis configured for coupling to a user's stoma and/or skin surrounding thestoma, such as a peristomal skin area.

The base plate comprises a first adhesive layer, also denoted centeradhesive layer. During use, the first adhesive layer adheres to theuser's skin (peristomal area) and/or to additional seals, such assealing paste, sealing tape and/or sealing ring. Thus, the firstadhesive layer may be configured for attachment of the base plate to theskin surface of a user. The first adhesive layer may have a stomalopening with a center point.

The first adhesive layer may be made of a first composition. The firstcomposition may comprise one or more polyisobutenes and/orstyrene-isoprene-styrene. The first composition may comprise one or morehydrocoloids.

The first composition may be a pressure sensitive adhesive compositionsuitable for medical purposes comprising a rubbery elastomeric base andone or more water soluble or water swellable hydrocolloids. The firstcomposition may comprise one or more polybutenes, one or more styrenecopolymers, one or more hydrocolloids, or any combination thereof. Thecombination of the adhesive properties of the polybutenes and theabsorbing properties of the hydrocolloids renders the first compositionsuitable for use in ostomy appliances. The styrene copolymer may forexample be a styrene-butadiene-styrene block copolymer or astyrene-isoprene-styrene block copolymer. Preferably, one or morestyrene-isoprene-styrene (SIS) block type copolymers are employed. Theamount of styrene block-copolymer may be from 5% to 20% of the totaladhesive composition. The butene component is suitably a conjugatedbutadiene polymer selected from polybutadiene, polyisoprene. Thepolybutenes are preferably present in an amount of from 35-50% of thetotal adhesive composition. Preferably, the polybutene ispolyisobutylene (PIB). Suitable hydrocolloids for incorporation in thefirst composition are selected from naturally occurring hydrocolloids,semisynthetic hydrocolloids and synthetic hydrocolloids. The firstcomposition may comprise 20-60% hydrocolloids. A preferred hydrocolloidis carboxymethylcellulose (CMC). The first composition may optionallycontain other components, such as fillers, tackifiers, plasticizers, andother additives.

The first adhesive layer may have a plurality of sensor point openings.A sensor point opening of the first adhesive layer is optionallyconfigured to overlap a part of an electrode, e.g. to form a sensorpoint.

The sensor point openings of the first adhesive layer may compriseprimary sensor point openings. The primary sensor point openings maycomprise one or more primary first sensor point openings and one or moreprimary second sensor point openings, the primary first sensor pointopenings configured to overlap parts of an electrode and the primarysecond sensor point openings configured to overlap parts of anotherelectrode different from the electrode at least partly overlapped by theprimary first sensor point openings.

The sensor point openings of the first adhesive layer may comprisesecondary sensor point openings. The secondary sensor point openings maycomprise one or more secondary first sensor point openings and one ormore secondary second sensor point openings, the secondary first sensorpoint openings configured to overlap parts of an electrode and thesecondary second sensor point openings configured to overlap parts ofanother electrode different from the electrode at least partlyoverlapped by the secondary first sensor point openings.

The sensor point openings of the first adhesive layer may comprisetertiary sensor point openings. The tertiary sensor point openings maycomprise one or more tertiary first sensor point openings and one ormore tertiary second sensor point openings, the tertiary first sensorpoint openings configured to overlap parts of an electrode and thetertiary second sensor point openings configured to overlap parts ofanother electrode different from the electrode at least partlyoverlapped by the tertiary first sensor point openings.

The first adhesive layer may have a substantially uniform thickness. Thefirst adhesive layer may have a thickness in the range from 0.1 mm to1.5 mm, e.g. in the range from 0.2 mm to 1.2 mm.

The first adhesive layer may have a primary thickness in a primary partof the first adhesive layer, e.g. in a primary region within a primaryradial distance or in a primary radial distance range from the centerpoint of the stomal opening. The primary thickness may be in the rangefrom 0.2 mm to 1.5 mm. such as about 1.0 mm. The primary radial distancemay be in the range from 20 mm to 50 mm, such as in the range from 25 mmto 35 mm, e.g. 30 mm.

The first adhesive layer may have a secondary thickness in a secondarypart of the first adhesive layer, e.g. in a secondary region outside asecondary radial distance or in a secondary radial distance range fromthe center point of the stomal opening. The secondary thickness may bein the range from 0.2 mm to 1.0 mm, such as about 0.5 mm. The secondaryradial distance may be in the range from 20 mm to 50 mm, such as in therange from 25 mm to 35 mm, e.g. 30 mm.

The base plate may comprise a second layer. The second layer may be anadhesive layer, also denoted rim adhesive layer. The second layer mayhave a second radial extension that is larger than a first radialextension of the first adhesive layer at least in a first angular rangeof the base plate. Accordingly, a part of a proximal surface of thesecond layer may be configured for attachment to the skin surface of auser. The part of a proximal surface of the second layer configured forattachment to the skin surface of a user is also denoted the skinattachment surface of the second adhesive layer. The second layer mayhave a stomal opening with a center point.

The second adhesive layer may be made of a second composition. Thesecond composition may comprise one or more polyisobutenes and/orstyrene-isoprene-styrene. The second composition may comprise one ormore hydrocoloids.

The second composition may be a pressure sensitive adhesive compositionsuitable for medical purposes comprising a rubbery elastomeric base andone or more water soluble or water swellable hydrocolloids. The secondcomposition may comprise one or more polybutenes, one or more styrenecopolymers, one or more hydrocolloids, or any combination thereof. Thecombination of the adhesive properties of the polybutenes and theabsorbing properties of the hydrocolloids renders the second compositionsuitable for use in ostomy appliances. The styrene copolymer may forexample be a styrene-butadiene-styrene block copolymer or astyrene-isoprene-styrene block copolymer. Preferably, one or morestyrene-isoprene-styrene (SIS) block type copolymers are employed. Theamount of styrene block-copolymer may be from 5% to 20% of the totaladhesive composition. The butene component is suitably a conjugatedbutadiene polymer selected from polybutadiene, polyisoprene. Thepolybutenes are preferably present in an amount of from 35-50% of thetotal adhesive composition. Preferably, the polybutene ispolyisobutylene (PIB). Suitable hydrocolloids for incorporation in thesecond composition are selected from naturally occurring hydrocolloids,semisynthetic hydrocolloids and synthetic hydrocolloids. The secondcomposition may comprise 20-60% hydrocolloids. A preferred hydrocolloidis carboxymethylcellulose (CMC). The second composition may optionallycontain other components, such as fillers, tackifiers, plasticizers, andother additives.

Different ratio of contents may change properties of the first and/orsecond adhesive layers. The second adhesive layer and the first adhesivelayer may have different properties. The second adhesive layer (secondcomposition) and the first adhesive layer (first composition) may havedifferent ratios of polyisobutenes, styrene-isoprene-styrene, and/orhydrocoloids. For example, the second adhesive layer may provide astronger attachment to the skin compared to attachment to the skinprovided by the first adhesive layer. Alternatively, or additionally,the second adhesive layer may be thinner than the first adhesive layer.Alternatively, or additionally, the second adhesive layer may be lesswater and/or sweat absorbing than the first adhesive layer.Alternatively, or additionally, the second adhesive layer may be lessmouldable than the first adhesive layer. The second adhesive layer mayprovide a second barrier against leakage.

The second layer may have a substantially uniform thickness. The secondlayer may have a thickness in the range from 0.1 mm to 1.5 mm, e.g. inthe range from 0.2 mm to 1.0 mm, such as 0.5 mm, 0.6 mm, or 0.7 mm.

The base plate comprises one or more electrodes, such as a plurality ofelectrodes, such as two, three, four, five, six, seven or moreelectrodes. The electrodes, e.g. some or all the electrodes, may bearranged between the first adhesive layer and the second adhesive layer.The electrodes may be arranged in an electrode assembly, e.g. anelectrode layer. An electrode comprises a connection part for connectingthe electrodes to other components and/or interface terminals. Anelectrode may comprise one or more conductor parts and/or one or moresensing parts. The electrode assembly may be arranged between the firstadhesive layer and the second adhesive layer. The base plate, e.g. theelectrode assembly, may comprise a first electrode, a second electrodeand optionally a third electrode. The base plate, e.g. the electrodeassembly, may comprise a fourth electrode and/or a fifth electrode. Thebase plate, e.g. the electrode assembly, optionally comprises a sixthelectrode. The base plate, e.g. the electrode assembly, may comprise aground electrode. The ground electrode may comprise a first electrodepart. The first electrode part of the ground electrode may form a groundfor the first electrode. The ground electrode may comprise a secondelectrode part. The second electrode part of the ground electrode mayform a ground for the second electrode. The ground electrode maycomprise a third electrode part. The third electrode part of the groundelectrode may form a ground for the third electrode. The groundelectrode may comprise a fourth electrode part. The fourth electrodepart of the ground electrode may form a ground for the fourth electrodeand/or the fifth electrode.

The ground electrode or electrode parts of the ground electrode may beconfigured as or form a (common) reference electrode for some or all ofthe other electrodes of the electrode assembly. The ground electrode mayalso be denoted reference electrode.

The electrodes are electrically conductive and may comprise one or moreof metallic (e.g. silver, copper, gold, titanium, aluminium, stainlesssteel), ceramic (e.g. ITO), polymeric (e.g. PEDOT, PANI, PPy), andcarbonaceous (e.g. carbon black, carbon nanotube, carbon fibre,graphene, graphite) materials.

Two electrodes of the electrode assembly may form a sensor. The firstelectrode and the ground electrode (e.g. first electrode part of theground electrode) may form a first sensor or first electrode pair. Thesecond electrode and the ground electrode (e.g. second electrode part ofthe ground electrode) may form a second sensor or second electrode pair.The third electrode and the ground electrode (e.g. third electrode partof the ground electrode) may form a third sensor or third electrodepair. The fourth electrode and the ground electrode (e.g. fourthelectrode part of the ground electrode) may form a fourth sensor orfourth electrode pair. The fifth electrode and the ground electrode(e.g. fifth electrode part of the ground electrode) may form a fifthsensor or fifth electrode pair.

The first electrode may form an open loop. The second electrode may forman open loop and/or the third electrode may form an open loop. Thefourth electrode may form an open loop. The fifth electrode may form anopen loop. Open loop electrode(s) enables electrode arrangement in fewor a single electrode layer.

The electrode assembly may comprise a support layer, also denoted asupport film. One or more electrodes may be formed, e.g. printed, on theproximal side of the support layer. One or more electrodes may beformed, e.g. printed, on the distal side of the support layer. Theelectrode assembly may have a stomal opening with a center point.

The support layer may comprise polymeric (e.g. polyurethane, PTFE, PVDF)and/or ceramic (e.g. alumina, silica) materials. In one or moreexemplary base plates, the support layer is made of thermoplasticpolyurethane (TPU). The support layer material may be made of orcomprise one or more of polyester, a thermoplastic elastomer (TPE),polyamide, polyimide, Ethylene-vinyl acetate (EVA), polyurea, andsilicones.

Exemplary thermoplastic elastomers of the support layer are styrenicblock copolymers (TPS, TPE-s), thermoplastic polyolefinelastomers (TPO,TPE-o), thermoplastic Vulcanizates (TPV, TPE-v), thermoplasticpolyurethanes (TPU), thermoplastic copolyester (TPC, TPE-E), andthermoplastic polyamides (TPA, TPE-A).

The electrode assembly/base plate may comprise a masking elementconfigured to insulate at least parts of the electrodes from the firstadhesive layer of the base plate. The masking element may comprise oneor more, such as a plurality of, sensor point openings. The sensor pointopenings may comprise primary sensor point openings and/or secondarysensor point openings. The sensor point openings may comprise tertiarysensor point opening(s). The sensor point openings may comprisequaternary sensor point opening(s) A sensor point opening of the maskingelement overlaps at least one electrode of the electrode assembly whenseen in the axial direction, e.g. to form a sensor point. For example, aprimary sensor point opening may overlap a part of the ground electrodeand/or a part of the fourth electrode. A secondary sensor point openingmay overlap a part of the fourth electrode and/or a part of the fifthelectrode. A tertiary sensor point opening may overlap a part of thefifth electrode and/or a part of the ground electrode.

The masking element may comprise one or more, such as a plurality of,terminal openings. The masking element may comprise polymeric (e.g.polyurethane, PTFE, PVDF) and/or ceramic (e.g. alumina, silica)materials. In one or more exemplary base plates, the masking element ismade of or comprises thermoplastic polyurethane (TPU). In one or moreexemplary base plates, the masking element is made of or comprisespolyester. The masking element material may be made of or comprise oneor more of polyester, a thermoplastic elastomer (TPE), polyimide,polyimide, Ethylene-vinyl acetate (EVA), polyurea, and silicones.

Exemplary thermoplastic elastomers of the masking element are styrenicblock copolymers (TPS, TPE-s), thermoplastic polyolefinelastomers (TPO,TPE-o), thermoplastic Vulcanizates (TPV, TPE-v), thermoplasticpolyurethanes (TPU), thermoplastic copolyester (TPC, TPE-E), andthermoplastic polyamides (TPA, TPE-A).

The base plate may comprise a first intermediate element. The firstintermediate element may be arranged between the electrodes/electrodelayer and the first adhesive layer and/or between the second layer andthe first adhesive layer. The first intermediate layer may be made of aninsulating material.

The base plate may comprise a release liner. The release liner is aprotective layer that protects adhesive layer(s) during transport andstorage and is peeled off by the user prior to applying the base plateon the skin. The release liner may have a stomal opening with a centerpoint.

The base plate may comprise a top layer. The top layer is a protectivelayer protecting the adhesive layer(s) from external strains and stresswhen the user wears the ostomy appliance. The electrodes, e.g. some orall the electrodes, may be arranged between the first adhesive layer andthe top layer. The top layer may have a stomal opening with a centerpoint. The top layer may have a thickness in the range from 0.01 mm to1.0 mm, e.g. in the range from 0.02 mm to 0.2 mm, such as 0.04 mm.

The base plate comprises a monitor interface. The monitor interface maybe configured for electrically and/or mechanically connecting the ostomyappliance (base plate) to the monitor device. The monitor interface maybe configured for wirelessly connecting the ostomy appliance (baseplate) to the monitor device. Thus, the monitor interface of the baseplate is configured to electrically and/or mechanically couple theostomy appliance and the monitor device.

The monitor interface of the base plate may comprise, e.g. as part of afirst connector of the monitor interface, a coupling part for forming amechanical connection, such as a releasable coupling between the monitordevice and the base plate. The coupling part may be configured to engagewith a coupling part of the monitor device for releasably coupling themonitor device to the base plate.

The monitor interface of the base plate may comprise, e.g. as part of afirst connector of the monitor interface, a plurality of terminals, suchas two, three, four, five, six, seven or more terminals, for formingelectrical connections with respective terminals of the monitor device.The monitor interface may comprise a ground terminal element forming aground terminal. The monitor interface may comprise a first terminalelement forming a first terminal, a second terminal element forming asecond terminal and optionally a third terminal element forming a thirdterminal. The monitor interface may comprise a fourth terminal elementforming a fourth terminal and/or a fifth terminal element forming afifth terminal. The monitor interface optionally comprises a sixthterminal element forming a sixth terminal. The terminal elements of themonitor interface may contact respective electrodes of the baseplate/electrode assembly. The first intermediate element may be arrangedbetween the terminal elements and the first adhesive layer. The firstintermediate element may cover or overlap terminal element(s) of thebase plate when seen in the axial direction. Thus, the first adhesivelayer may be protected or experience more evenly distributed mechanicalstress from the terminal elements of the base plate, in turn reducingthe risk of terminal elements penetrating or otherwise damaging thefirst adhesive layer. The first intermediate element may protect ormechanically and/or electrically shield the first adhesive layer fromthe terminal elements of the base plate.

The base plate may comprise a coupling ring or other coupling member forcoupling an ostomy pouch to the base plate (two-part ostomy appliance).The center point may be defined as a center of the coupling ring.

The base plate has a stomal opening with a center point. The size and/orshape of the stomal opening is typically adjusted by the user or nursebefore application of the ostomy appliance to accommodate the user'sstoma. In one or more exemplary base plates, the user forms the stomalopening during preparation of the base plate for application.

The monitor device comprises a processor and one or more interfaces,such as a first interface and/or a second interface. The monitor devicemay comprise a memory for storing ostomy data.

In one or more exemplary monitor devices, the processor is configured toapply a processing scheme, the first interface is connected to theprocessor and the memory, and the first interface is configured forcollecting ostomy data from the base plate coupled to the firstinterface. The ostomy data may comprise one or more, such as all, offirst ostomy data from a first electrode pair of the base plate, secondostomy data from a second electrode pair of the base plate, and thirdostomy data from a third electrode pair of the base plate. A secondinterface is connected to the processor. To apply a processing schememay comprise one or more of obtain first parameter data based on thefirst ostomy data; obtain second parameter data based on the secondostomy data; and obtain third parameter data based on the third ostomydata. To apply a processing scheme may comprise determine an operatingstate of the base plate of the ostomy appliance based on one or more,such as all, of the first parameter data, the second parameter data andthe third parameter data. The operating state may be indicative of adegree of radial erosion of the base plate, such as of the firstadhesive layer, and/or an acute leakage risk for the ostomy appliance.The monitor device is configured to, in accordance with a determinationthat the operating state is a first operating state, transmit a firstmonitor signal comprising monitor data indicative of the first operatingstate of the base plate via the second interface; and/or in accordancewith a determination that the operating state is a second operatingstate, transmit a second monitor signal comprising monitor dataindicative of the second operating state of the base plate via thesecond interface.

In one or more exemplary monitor devices, the first operating state ofthe base plate corresponds to a situation wherein the first adhesivelayer of the base plate has experienced a first degree of radialerosion, e.g. the first adhesive layer is eroded to a first radialdistance of the first electrode pair but not to a second radial distanceof the second electrode pair.

In one or more exemplary monitor devices, the second operating state ofthe base plate corresponds to a situation wherein the first adhesivelayer of the base plate has experienced a second degree of radialerosion, e.g. the first adhesive layer is eroded to the second radialdistance of the second electrode pair but not to a third radial distanceof the third electrode pair.

To obtain first parameter data based on the first ostomy data maycomprise determining one or more first parameters based on the firstostomy data. To obtain second parameter data based on the second ostomydata may comprise determining one or more second parameters based on thesecond ostomy data. To obtain third parameter data based on the thirdostomy data may comprise determining one or more third parameters basedon the third ostomy data. In one or more exemplary monitor devices,determination of an operating state may be based on one or more firstparameters, such as first primary parameter and/or first secondaryparameter of first parameter data. In one or more exemplary monitordevices, determination of an operating state may be based on one or moresecond parameters, such as second primary parameter and/or secondsecondary parameter of the second parameter data. In one or moreexemplary monitor devices, determination of an operating state may bebased on one or more third parameters, such as third primary parameterand/or third secondary parameter of the third parameter data. In one ormore exemplary monitor devices, determination of an operating state maybe based on one or more fourth parameters, such as fourth primaryparameter and/or fourth secondary parameter of the fourth parameterdata.

The first parameter data, the second parameter data, and the thirdparameter data may be indicative of resistance between the firstelectrode pair, the second electrode pair, and the third electrode pair,respectively.

The first parameter data, the second parameter data, and the thirdparameter data may be indicative of a rate of change in resistancebetween the first electrode pair, the second electrode pair, and thethird electrode pair, respectively.

In one or more exemplary monitor devices, to determine an operatingstate of the base plate is based on a first criteria set based on thefirst parameter data and/or the second parameter data, wherein theoperating state is determined to be the first operating state if thefirst criteria set is satisfied. The first criteria set may comprise oneor more first criteria based on one or more of first parameter data,second parameter data and third parameter data. The first criteria setmay comprise a first primary criterion based on the first parameterdata. The first criteria set may comprise a first secondary criterionbased on the second parameter data. The first criteria set may comprisea first tertiary criterion based on the third parameter data.

In one or more exemplary monitor devices, to determine an operatingstate of the base plate may be based on a first threshold set comprisingone or a plurality of first threshold values. The first threshold setmay comprise one or a plurality of threshold values, e.g. to be appliedin the first criteria set. The first threshold set may comprise a firstprimary threshold value. The first threshold set may comprise a firstsecondary threshold value. The first threshold set may comprise a firsttertiary threshold value.

The first criteria set may be given by

-   -   (P_1_1<TH_1_1),    -   (P_2_1>TH_1_2), and    -   (P_3_1>TH_1_3),        wherein P_1_1 is a first primary parameter based on the first        parameter data, TH_1_1 is a first primary threshold value, P_2_1        is a second primary parameter based on the second parameter        data, TH_1_2 is a first secondary threshold value, P_3_1 is a        third primary parameter based on the third parameter data, and        TH_1_3 is a first tertiary threshold value, and wherein the        first operating state is indicative of low degree of radial        erosion on the base plate. The first threshold values (TH_1_1,        TH_1_2 and TH_1_3) may be the same or different, e.g. depending        on the electrode configuration of the base plate. The first        tertiary criterion (P_3_1<TH_1_3) may be omitted in the first        criteria set.

The first primary parameter P_1_1 may be indicative of the resistancebetween the first electrode pair (first electrode and first electrodepart of the ground electrode) of the base plate.

The second primary parameter may be indicative of the resistance betweenthe second electrode pair (second electrode and second electrode part ofthe ground electrode) of the base plate.

The third primary parameter may be indicative of resistance between thethird electrode pair (third electrode and third electrode part of theground electrode) of the base plate.

In one or more exemplary monitor devices, to determine an operatingstate of the base plate is based on a second criteria set based on thesecond parameter data and/or the third parameter data, wherein theoperating state is determined to be the second operating state if thesecond criteria set is satisfied. The second criteria set may be basedon the first parameter data.

The second criteria set may comprise one or more second criteria basedon one or more of first parameter data, second parameter data and thirdparameter data. The second criteria set may comprise a second primarycriterion based on the first parameter data. The second criteria set maycomprise a second secondary criterion based on the second parameterdata. The second criteria set may comprise a second tertiary criterionbased on the third parameter data.

In one or more exemplary monitor devices, to determine an operatingstate of the base plate is based on a second threshold set comprisingone or a plurality of second threshold values. The second threshold setmay comprise one or a plurality of threshold values, e.g. to be appliedin the second criteria set. The second threshold set may comprise asecond primary threshold value. The second threshold set may comprise asecond secondary threshold value. The second threshold set may comprisea second tertiary threshold value.

The second criteria set may be given by

-   -   (P_1_1<TH_2_1),    -   (P_2_1<TH_2_2), and    -   (P_3_1>TH_2_3)        wherein P_1_1 is a first primary parameter based on the first        parameter data and indicative of the resistance between the        first electrode pair, TH_2_1 is a second primary threshold        value, P_2_1 is a second primary parameter based on the second        parameter data and indicative of the resistance between the        second electrode pair, TH_2_2 is a second secondary threshold        value, P_3_1 is a third primary parameter based on the third        parameter data and indicative of the resistance between the        third electrode pair, TH_2_3 is a second tertiary threshold        value, and wherein the second operating state is indicative of        medium degree of radial erosion on the base plate. The second        threshold values (TH_2_1, TH_2_2 and TH_2_3) may be the same or        different, e.g. depending on the electrode configuration of the        base plate. The second primary criterion (P_1_1<TH_2_1) and/or        the second tertiary criterion (P_3_1>TH_2_3) may be omitted in        the second criteria set.

In one or more exemplary monitor devices, to determine an operatingstate of the base plate is based on a default criteria set based on thefirst parameter data, wherein the operating state is determined to bethe default operating state if the default criteria set is satisfied,and in accordance with a determination that the operating state is thedefault operating state, transmit a default monitor signal comprisingmonitor data indicative of the default operating state of the ostomyappliance.

The default criteria set may be given by

-   -   (P_1_1>TH_D_1),    -   (P_2_1>TH_D_2), and    -   (P_3_1>TH_D_3)        wherein P_1_1 is a first primary parameter based on the first        parameter data and indicative of the resistance between the        first electrode pair, TH_D_1 is a default primary threshold        value, P_2_1 is a second primary parameter based on the second        parameter data and indicative of the resistance between the        second electrode pair, TH_D_2 is a default secondary threshold        value, P_3_1 is a third primary parameter based on the third        parameter data and indicative of the resistance between the        third electrode pair, TH_D_3 is a default tertiary threshold        value, and wherein the default operating state is indicative of        very low or no degree of radial erosion on the base plate. The        default threshold values (TH_D_1, TH_D_2 and TH_D_3) may be the        same or different, e.g. depending on the electrode configuration        of the base plate.

In one or more exemplary monitor devices, to determine an operatingstate of the base plate is based on a third criteria set based on thethird parameter data, wherein the operating state is determined to bethe third operating state if the third criteria set is satisfied, and inaccordance with a determination that the operating state is the thirdoperating state, transmit a third monitor signal comprising monitor dataindicative of the third operating state of the ostomy appliance.

In one or more exemplary monitor devices, the third operating state ofthe base plate corresponds to a situation wherein the first adhesivelayer of the base plate has experienced a third degree of radialerosion, e.g. the first adhesive layer is eroded to the third radialdistance of the third electrode pair.

The third criteria set may be given by

-   -   (P_1_1<TH_3_1),    -   (P_2_1<TH_3_2), and    -   (P_3_1<TH_3_3)        wherein P_1_1 is a first primary parameter based on the first        parameter data and indicative of the resistance between the        first electrode pair, TH_3_1 is a third primary threshold value,        P_2_1 is a second primary parameter based on the second        parameter data and indicative of the resistance between the        second electrode pair, TH_3_2 is a third secondary threshold        value, P_3_1 is a third primary parameter based on the third        parameter data and indicative of the resistance between the        third electrode pair, TH_3_3 is a third tertiary threshold        value, and wherein the third operating state is indicative of        high degree of radial erosion on the base plate. The third        threshold values (TH_3_1, TH_3_2 and TH_3_3) may be the same or        different, e.g. depending on the electrode configuration of the        base plate. The third primary criterion (P_1_1<TH_3_1) and/or        the third secondary criterion (P_2_1<TH_3_2) may be omitted in        the third criteria set.

In one or more exemplary monitor devices, the ostomy data comprisesfourth ostomy data from a fourth electrode pair of the base plate. Toapply a processing scheme may comprise to obtain fourth parameter databased on the fourth ostomy data, and determine an operating state of thebase plate of the ostomy appliance based on the fourth parameter data.The monitor device may be configured to, in accordance with adetermination that the operating state is a fourth operating state,transmit a fourth monitor signal comprising monitor data indicative ofthe fourth operating state of the ostomy appliance.

In one or more exemplary monitor devices, the fourth operating state ofthe base plate corresponds to a situation, wherein the fourth electrodepair detects fluid, such as output, between the distal surface of firstadhesive layer and the skin of the user at a fourth radial distance, andthus there is a high risk of leakage from the ostomy appliance in thefourth operating state.

The fourth criteria set may be given by

-   -   (P_4_1<TH_4_4)        wherein P_4_1 is a fourth primary parameter based on the fourth        parameter data and indicative of the resistance between the        fourth electrode pair and TH_4_4 is a fourth quaternary        threshold value, and wherein the fourth operating state is        indicative of high risk of leakage from the ostomy appliance.

The monitor device comprises a monitor device housing optionally made ofa plastic material. The monitor device housing may be an elongatehousing having a first end and a second end. The monitor device housingmay have a length or maximum extension along a longitudinal axis in therange from 1 cm to 15 cm. The monitor device housing may have a width ormaximum extension perpendicular to the longitudinal axis in the rangefrom 0.5 cm to 3 cm. The monitor device housing may be curve-shaped.

The monitor device comprises a first interface. The first interface maybe configured as an appliance interface for electrically and/ormechanically connecting the monitor device to the ostomy appliance.Thus, the appliance interface is configured to electrically and/ormechanically couple the monitor device and the ostomy appliance. Thefirst interface may be configured as an accessory device interface forelectrically and//or mechanically connecting the monitor device to anaccessory device, such as a docking station. The first interface may beconfigured for coupling to a docking station of the ostomy system, e.g.for charging the monitor device and/or for data transfer between themonitor device and the docking station.

The first interface of the monitor device may comprise a plurality ofterminals, such as two, three, four, five, six, seven or more terminals,for forming electrical connections with respective terminals and/orelectrodes of the ostomy appliance. One or more terminals of the firstinterface may be configured for forming electrical connections with anaccessory device, e.g. with respective terminals of a docking station.The first interface may comprise a ground terminal. The first interfacemay comprise a first terminal, a second terminal and optionally a thirdterminal. The first interface may comprise a fourth terminal and/or afifth terminal. The first interface optionally comprises a sixthterminal. In one or more exemplary monitor devices, the first interfacehas M terminals, wherein M is an integer in the range from 4 to 8.

The first interface of the monitor device may comprise a coupling partfor forming a mechanical connection, such as a releasable couplingbetween the monitor device and the base plate. The coupling part and theterminals of the first interface form (at least part of) a firstconnector of the monitor device.

The monitor device comprises a power unit for powering the monitordevice. The power unit may comprise a battery. The power unit maycomprise charging circuitry connected to the battery and terminals ofthe first interface for charging the battery via the first interface,e.g. the first connector. The first interface may comprise separatecharging terminal(s) for charging the battery.

The monitor device may comprise a sensor unit with one or more sensor.The sensor unit is connected to the processor for feeding sensor data tothe processor. The sensor unit may comprise an accelerometer for sensingacceleration and provision of acceleration data to the processor. Thesensor unit may comprise a temperature sensor for provision oftemperature data to the processor.

The monitor device comprises a second interface connected to theprocessor. The second interface may be configured as an accessoryinterface for connecting, e.g. wirelessly connecting, the monitor deviceto one or more accessory devices. The second interface may comprise anantenna and a wireless transceiver, e.g. configured for wirelesscommunication at frequencies in the range from 2.4 to 2.5 GHz. Thewireless transceiver may be a Bluetooth transceiver, i.e. the wirelesstransceiver may be configured for wireless communication according toBluetooth protocol, e.g. Bluetooth Low Energy, Bluetooth 4.0, Bluetooth5. The second interface optionally comprises a loudspeaker and/or ahaptic feedback element for provision of an audio signal and/or hapticfeedback to the user, respectively.

In one or more exemplary ostomy systems, the monitor device forms anintegrated part of the ostomy appliance, e.g. the monitor device mayform an integrated part of a base plate of the ostomy appliance.

The ostomy system may comprise a docking station forming an accessorydevice of the ostomy system and/or in addition to the accessory device.The docking station may be configured to electrically and/ormechanically couple the monitor device to the docking station.

The docking station may comprise a docking monitor interface. Thedocking monitor interface may be configured for electrically and/ormechanically connecting the monitor device to the docking station. Thedocking monitor interface may be configured for wirelessly connectingthe monitor device to the docking station. The docking monitor interfaceof the docking station may be configured to electrically and/ormechanically couple the docking station and the monitor device.

The docking monitor interface of the docking station may comprise, e.g.as part of a first connector of the docking monitor interface, acoupling part for forming a mechanical connection, such as a releasablecoupling between the monitor device and the docking station. Thecoupling part may be configured to engage with a coupling part of themonitor device for releasably coupling the monitor device to the dockingstation.

The docking monitor interface of the docking station may comprise, e.g.as part of a first connector of the docking monitor interface, aplurality of terminals, such as two, three, four, five, six, seven ormore terminals, for forming electrical connections with respectiveterminals of the monitor device. The docking monitor interface maycomprise a ground terminal. The docking monitor interface may comprise afirst terminal and/or a second terminal. The docking station maycomprise a third terminal. The docking monitor interface may comprise afourth terminal and/or a fifth terminal. The docking monitor interfaceoptionally comprises a sixth terminal.

The present disclosure provides a method, performed in an accessorydevice, for communicating the leakage state of the ostomy appliance,which in turn enables a monitoring of the ostomy appliance at theaccessory device. The accessory device comprises an interface configuredto communicate with one or more devices of an ostomy system. The one ormore devices comprise a monitor device, and/or the ostomy applianceconfigured to be placed on a skin surface of a user or on any additionalseals. The method comprises obtaining (e.g. receiving and/or retrieving)monitor data from the one or more devices. The monitor data isindicative of presence of fluid at a proximal side of the first adhesivelayer of the ostomy appliance, towards the skin surface. In one or moreexemplary methods, the method comprises determining a leakage state atthe proximal side of the first adhesive layer of the ostomy appliancebased on the monitor data, and communicating the leakage state of theostomy appliance via the interface. In other words, the monitor data canbe seen as indicative of a moisture condition at a proximal side (orproximal surface) of the first adhesive layer of the ostomy appliance.The presence of fluid at the proximal side (or proximal surface) of thefirst adhesive layer of the ostomy appliance may be derived at theaccessory device based on monitor data.

In one or more exemplary methods, the method may comprise determining aleakage state of the ostomy appliance based on the monitor dataobtained. The leakage state may be indicative of presence of output(e.g. feces) at the proximal side or surface of the first adhesive layerof the ostomy appliance. A leakage state in the present disclosure maybe indicative of the dynamic internal state of the ostomy appliance,related to the leakage of output (e.g. faecal material, partial leakageor full leakage), such as severity, imminence, timing of leakage at aproximal side (or proximal surface) of the ostomy appliance. Byidentifying early the presence of fluid, and determining a leakage stateas disclosed herein, the likelihood of ending in a situation whereoutput has reached beyond the proximal side (or proximal surface), e.g.out to the clothes of the user, is significantly reduced. Such situationis extremely difficult for the user of the ostomy appliance, due tohygiene and social acceptance.

Presence of fluid on the proximal side (or proximal surface) of thefirst adhesive layer may affect the adhesive performance of the ostomyappliance. Presence of output on the proximal side of the first adhesivelayer affects wear property, e.g. wear time and/or wear comfort of theostomy appliance.

A leakage state in the present disclosure may be configured to indicateof whether the ostomy appliance needs to be changed immediately based onpresence of fluid at a proximal side (or proximal surface) of a firstadhesive layer of the ostomy appliance. For example, the leakage statemay be indicative of high risk of output going beyond the proximal side(or proximal surface) depending on a corresponding moisture patterntype. For example, the leakage state may be indicative of one or more ofseverity, imminence of a severe leakage beyond base plate surface,location, timing of the leakage. For example, the leakage state may beindicative of the severity (e.g. no leakage, low, medium, high) and/orimminence of the required change (e.g. no leakage, low, medium, acute).The leakage state may comprise N leakage states, where N is an integer,e.g. for N sensing zones or zones of the base plate. The leakage statemay comprise a first leakage state indicative of leakage in a primarysensing zone or in a first zone. The first leakage state may comprise afirst primary leakage state, a first secondary leakage state, a firsttertiary leakage state, and/or a first quaternary leakage state (e.g.change NOW, check, change in X time, no leakage).

The method comprises communicating (e.g. outputting, transmitting,displaying) the leakage state of the ostomy appliance via the interface,e.g. to the user and/or the one or more devices of the ostomy system.

It is an advantage of the present disclosure that a user of an ostomyappliance or a health care professional is able to be advised on theleakage state of the ostomy appliance and plan the change of the ostomyappliance. Communication of the leakage states of the ostomy applianceis useful in helping to reduce the risk of a user experiencing leakagefrom an ostomy appliance (e.g. faecal material leakage from the ostomyappliance), which stays long on the skin and increases risks of skindamage to a user (due to e.g. malfunctions and misplacement of theostomy appliance on the stoma). In particular, determination andcommunication of leakage state according to the present disclosure isperformed based on monitor data indicative of a presence of fluid at theproximal side (or proximal surface) of the ostomy appliance which is notbe visible to the user (because it is under the base plate of the ostomyappliance) when the ostomy appliance is worn. This results in providinga clear improvement of the comfort provided by the ostomy appliance inthat leakage (incl. partial leakage) of faecal material, which isharmful to the skin is immediately communicated to the user via theaccessory device and thereby allowing for a change to happen as soon aspossible.

The present disclosure provides an efficient, and easy-to-usecommunication of a leakage state of an ostomy appliance system with ahigh degree of comfort for a user. The present disclosure allows toderive and instantly (e.g. substantially in real time) communicate theleakage state based on monitor data that is not accessible or visible bythe user or the health care professional. In other words, the disclosedmethod allows to indicate the dynamic internal state of the ostomyappliance to a user, which results in preventing situations whereleakage reached out to the clothes of the user and noticeable for othersin the vicinity and eventually improving the life of the ostomate.

In one or more exemplary methods, the ostomy appliance comprises anostomy pouch and a base plate. In one or more exemplary methods, thebase plate comprises a first adhesive layer having a proximal side (orproximal surface). During use, a proximal surface at the proximal sideof the first adhesive layer adheres to the user's skin in the peristomalarea and/or to additional seals, such as sealing paste, sealing tapeand/or sealing ring. In one or more exemplary methods, obtaining themonitor data comprises obtaining the monitor data indicative of thepresence of fluid at the proximal side of a first adhesive layer of thebase plate. The presence of fluid creates a conductive path at theproximal side of the first adhesive layer, such as on the proximalsurface of the first adhesive layer.

In one or more exemplary methods, the base plate comprises a pluralityof electrodes configured to detect presence of fluid on the proximalside (or proximal surface) in a primary sensing zone (and/or in a firstzone) and a secondary sensing zone (and/or in a second zone). Theplurality of electrodes may include a first leakage electrode, a secondleakage electrode, and a third leakage electrode. The first leakageelectrode may serve as a ground electrode. The second leakage electrodemay serve as the fourth electrode of the base plate embodiment disclosedherein. The third leakage electrode may serve as the fifth electrode ofthe base plate embodiment disclosed herein. Obtaining monitor data maycomprise obtaining data representative of detection of fluid on theproximal side (or proximal surface) in the primary sensing zone and thesecondary sensing zone. The first adhesive layer may have a stomalopening with a center point. The primary sensing zone may be arranged ina primary angle space from the center point of the first adhesive layerand the secondary sensing zone may be arranged in a secondary anglespace from the center point of the first adhesive layer. The primaryangle space may span a primary angle in the range from 45° to 315°. Thesecondary angle space may span a secondary angle in the range from 45°to 315°. The primary sensing zone and the secondary sensing zone may beseparate sensing zones, such as non-overlapping sensing zones. The firstleakage electrode may comprise one or more primary first sensing partsarranged in the primary sensing zone. The second leakage electrode maycomprise one or more primary second sensing parts arranged in theprimary sensing zone. The second leakage electrode may comprise one ormore secondary second sensing parts arranged in the secondary sensingzone. The third leakage electrode may comprise one or more secondarythird sensing parts arranged in the secondary sensing zone.

In one or more exemplary methods, the plurality of electrodes may beconfigured to detect presence of fluid output on the proximal side in atertiary sensing zone, the tertiary sensing zone arranged in a tertiaryangle space from the center point of the first adhesive layer. Thetertiary angle space may span a tertiary angle in the range from 45° to180°. The primary sensing zone and the tertiary sensing zone may beseparate sensing zones. The first leakage electrode may comprise one ormore tertiary first sensing parts arranged in the tertiary sensing zone.The third leakage electrode may comprise one or more tertiary thirdsensing parts arranged in the tertiary sensing zone.

In one or more exemplary methods, the plurality of electrodes of thebase plate comprises a ground electrode, a first electrode, a secondelectrode, and a third electrode, wherein the plurality of electrodes isconfigured to detect presence of fluid on the proximal side in a firstzone, a second zone, a third zone of the base plate. The first zone maybe at a first radial distance from a center point of a stomal opening ofthe base plate. The second zone may be at a second radial distance fromthe center point of the stomal opening of the base plate. The third zonemay be at a third radial distance from the center point of the stomalopening of the base plate. In one or more exemplary methods, thelocalized monitor data may be with respect to a first zone, a secondzone, and/or a third zone.

In one or more exemplary methods, the plurality of electrodes mayinclude a first leakage electrode, a second leakage electrode, a thirdleakage electrode, a ground electrode, a first electrode, a secondelectrode, and/or a third electrode, any electrode with the groundelectrode may be considered to form a sensor. For example, the monitordata may comprise a first parameter data indicative of resistancebetween electrodes of a first sensor, a second parameter data indicativeof resistance between electrodes of a second sensor, and/or a thirdparameter data indicative of resistance between electrodes of a thirdsensor. There may be a fourth parameter data indicative of resistancebetween electrodes of a fourth sensor.

Full leakage may correspond to a situation where output covers theproximal surface of the first adhesive layer, e.g. where output isdetected by the plurality of electrodes of the base plate. Partialleakage may correspond to a situation where output covers partially theproximal surface of the first adhesive layer, e.g. where output isdetected by a part of the plurality of electrodes of the base plate.

In one or more exemplary methods, the monitor data comprises ostomy dataand/or parameter data. For example, the parameter data is derived basedon ostomy data. Ostomy data or parameter data based on the ostomy dataare obtained from electrodes/sensors of the ostomy appliance with e.g. amonitor device or an accessory device. The monitor device may beconfigured to process the ostomy data and/or parameter data based on theostomy data to determine monitor data that are transmitted to theaccessory device.

In one or more exemplary methods, a plurality of electrodes configuredto detect presence of fluid on the proximal side in a primary sensingzone (and/or first zone) and a secondary sensing zone (and/or secondzone) by measuring electrical properties of the first adhesive layer.The electrical properties may be indicative of a conductive path in thefirst adhesive layer, thereby indicative of the presence of fluid at theproximal side of the first adhesive layer of the ostomy appliance. Inone or more exemplary methods, obtaining monitor data comprisesobtaining data representative of the measurements of the electricalproperties at the proximal side of the first adhesive layer. In one ormore exemplary methods, the ostomy data and/or parameter data areindicative of resistance between any two of the plurality of electrodes,capacitance and/or inductance between any two of the plurality ofelectrodes and/or any change thereof. In one or more exemplary methods,the ostomy data and/or parameter data are indicative of a change inresistance, capacitance and/or inductance between electrodes. In one ormore exemplary methods, the ostomy data and/or parameter data comprisestiming information, such as timestamped data or information from whichtiming is derivable.

In one or more exemplary methods, the monitor data comprises localizedmonitor data with respect to a location and/or a zone at the proximalside of the first adhesive layer of the base plate. Determining theleakage state may comprise determining a leakage location and/or aleakage time information. The location and/or region at the proximalside of the first adhesive layer of the base place may be related to aposition at the proximal side of the first adhesive layer whereelectrical properties have been measured by the one or more electrodes.In one or more exemplary methods, obtaining the monitor data comprisesobtaining (e.g. receiving from one or more devices in the ostomy system,and/or retrieving from one or more devices in the ostomy system)localized monitor data with respect to a location and/or zone at theproximal side of the first adhesive layer of the base plate. In one ormore exemplary methods, the localized monitor data may be with respectto a first location, a second location, a third location. In one or moreexemplary methods, the localized monitor data may be with respect to afirst zone, a second zone, and/or a third zone on proximal side of firstadhesive layer of the base plate. The leakage state of the ostomyappliance may be based on the moisture pattern type determined usinge.g. parameter data obtained from one or more devices, such as a monitordevice coupled with the base plate having e.g. electrodes placed inrespective zones of the base plate (such as electrodes of FIG. 6 and/orsensor points openings of FIG. 7).

In one or more exemplary methods, the monitor data may comprise firstlocalized monitor data indicative of presence of fluid at a firstlocation of the proximal side of the first adhesive layer of base plateor at a first zone of the proximal side of the first adhesive layer ofbase plate, second localized monitor data indicative of presence offluid at a second location of the proximal side of the first adhesivelayer of base plate or at a second zone of the proximal side of thefirst adhesive layer of base plate. For example, parameter data maycomprise first parameter data indicative of the presence of fluid at afirst zone and/or a primary sensing zone. For example, parameter datamay comprise second parameter data indicative of the presence of fluidat a second zone and/or a secondary sensing zone. For example, parameterdata may comprise third parameter data indicative of the presence offluid at a third zone, and/or a tertiary sensing zone.

In one or more exemplary methods, determining the leakage state of theostomy appliance based on the monitor data comprises determining one ormore moisture pattern types based on the monitor data, such as based onthe ostomy data and/or the parameter data (e.g. first parameter data andoptionally second parameter data), such as based on measurementsobtained by the electrodes, such as measurements of resistance,capacitance and/or inductance, such as timing information, for e.g. afirst primary sensing zone (and/or first zone), and optionally a secondprimary sensing zone (and/or second zone). The moisture pattern type isoptionally indicative of leakage risk of the ostomy appliance and/orindicative of the risk of skin damage to the user of the ostomy system.In one or more exemplary methods, determining the leakage state of theostomy appliance based on the monitor data comprises determining one ormore moisture pattern types based on the first parameter data (andoptionally second parameter data and optionally a third parameter).

In one or more exemplary methods, determining one or more moisturepattern types may comprise selecting a moisture pattern type from a setof predefined moisture pattern types. The set of predefined moisturepattern types may comprise a number K of moisture pattern types, such asat least three moisture pattern types, at least four moisture patterntypes, at least five moisture pattern types. The number K of moisturepattern types may be in the range from four to twenty.

In one or more exemplary methods, the method comprises determiningwhether the leakage state fulfils a leakage criterion indicative ofleakage risk (e.g. high risk of a severe leakage), and performing thestep of communicating the leakage state when the leakage state fulfilsthe leakage criterion. The leakage criterion may comprise one or morecriteria, such as first criteria, second criteria, third criteria.

In one or more exemplary methods, determining the leakage state of theostomy appliance based on the monitor data comprises deriving theleakage state based on the one or more moisture pattern types, such asderiving a first leakage state based on a first moisture pattern type,deriving a second leakage state based on a second moisture pattern type,and/or deriving a third leakage state based on a third moisture patterntype.

In one or more exemplary methods, determining one or more moisturepattern types comprises determining whether at least one of the firstparameter data, the second parameter data, and optionally the thirdparameter data meets one or more first criteria in any one or more ofthe primary, secondary and tertiary sensing zone (and/or any one or moreof the first, second, and third zone) respectively, and the moisturepattern type is set to the first moisture pattern type in any one ormore of the primary, secondary and tertiary sensing zone (and/or any oneor more of the first, second, and third zone) if the first criteria aremet for the first parameter data, the second parameter data, and/or thethird parameter data respectively. The leakage criterion may comprisefirst criteria, and when the first criteria are met, the leakagecriterion is met. For example, the first criteria may comprise a firstprimary criterion based on the first parameter data, a first secondarycriterion based on the second parameter data, and optionally a firsttertiary criterion based on the third parameter data. For example, thefirst criteria may be given by e.g.:

-   -   (P_1_1<TH_1_1),    -   (P_2_1<TH_1_2), and    -   (P_3_1<TH_1_3),        wherein P_1_1 is a first primary parameter based on the first        parameter data, TH_1_1 is a first primary threshold value, P_2_1        is a second primary parameter based on the second parameter        data, TH_1_2 is a first secondary threshold value, P_3_1 is a        third primary parameter based on the third parameter data, and        TH_1_3 is a first tertiary threshold value. The first moisture        pattern type may be indicative of a first primary leakage state,        which is indicative of high risk (e.g. high severity and/or high        imminence) of leakage in the primary sensing zone and/or in the        first zone. The first moisture pattern type may be indicative of        a second primary leakage state, which is indicative of high risk        (e.g. high severity and/or high imminence of highly severe        leakage) of leakage in the secondary sensing zone and/or in the        second zone. The first moisture pattern type may be indicative        of a third primary leakage state, which is indicative of high        risk (e.g. high severity and/or high imminence of highly severe        leakage) of leakage in the tertiary sensing zone and/or in the        third zone.

In one or more exemplary methods, determining one or more moisturepattern types comprises determining whether at least one of the firstparameter data, the second parameter data, and the third parameter datameets one or more second criteria in any one or more of the primary,secondary and tertiary sensing zone (and/or any one or more of thefirst, second, and third zone) respectively, and the moisture patterntype is set to the second type in any one or more of the primary,secondary and tertiary sensing zone (and/or any one or more of thefirst, second, and third zone) respectively if the second criteria aremet for the corresponding parameter data amongst the first parameterdata, the second parameter data, and the third parameter data. Forexample, the second criteria may be given by e.g.:

-   -   (P_1_1>TH_2_1),    -   (P_2_1>TH_2_2), and    -   (P_3_1>TH_2_3)        wherein P_1_1 is a first primary parameter based on the first        parameter data, TH_2_1 is a second primary threshold value,        P_2_1 is a second primary parameter based on the second        parameter data, TH_2_2 is a second secondary threshold value,        P_3_1 is a third primary parameter based on the third parameter        data, TH_2_3 is a second tertiary threshold value. The second        moisture pattern type may be indicative of a first secondary        leakage state, which is indicative of low risk (e.g. low        severity and/or low imminence) of leakage in the primary sensing        zone and/or first zone. The second moisture pattern type may be        indicative of a second secondary leakage state, which is        indicative of low risk (e.g. low severity and/or low imminence        of highly severe leakage) of leakage in the secondary sensing        zone and/or second zone. The second moisture pattern type may be        indicative of a third secondary leakage state, which is        indicative of low risk (e.g. low severity and/or low imminence        of highly severe leakage) of leakage in the tertiary sensing        zone and/or in the third zone. The second criteria may be        comprised in the leakage criterion wherein when the second        criteria are met, the leakage criterion is met.

In one or more exemplary methods, determining one or more moisturepattern types comprises determining whether at least one of the firstparameter data, the second parameter data, and/or the third parameterdata meets one or more third criteria in any one or more of the primary,secondary, and tertiary sensing zone (and/or any one or more of thefirst, second, and third zone) respectively. The moisture pattern typemay be set to the third moisture pattern type in any one or more of theprimary, secondary and tertiary sensing zone (and/or any one or more ofthe first, second, and third zone) if the third criteria are met for thecorresponding parameter data amongst the first parameter data, thesecond parameter data, and the third parameter data. In one or moreexemplary methods, the third criteria are given by

-   -   (P_1_1>TH_3_1),    -   (P_2_1>TH_3_2), and    -   (P_3_1>TH_3_3),        wherein P_1_1 is a first primary parameter, optionally        indicative of resistance between respective electrodes of a        first sensor, based on the first parameter data, TH_3_1 is a        third primary threshold value, P_2_1 is a second primary        parameter, optionally indicative of resistance between        respective electrodes of a second sensor, based on the second        parameter data, TH_3_2 is a third secondary threshold value,        P_3_1 is a third primary parameter, optionally indicative of        resistance between respective electrodes of a third sensor,        based on the third parameter data, TH_3_3 is a third tertiary        threshold value. The third moisture pattern type may be        indicative of a first tertiary leakage state, which is        indicative of very low risk (e.g. very low severity and/or very        low imminence of severe leakage) of leakage in the primary        sensing zone and/or the first zone. The third moisture pattern        type is indicative of a second tertiary leakage state, which is        indicative of very low risk (e.g. very low severity and/or very        low imminence of severe leakage) of leakage in the tertiary        sensing zone and/or the third zone. The third moisture pattern        type may be indicative of a third tertiary leakage state, which        is indicative of very low risk (e.g. very low severity and/or        very low imminence of severe leakage) of leakage in the tertiary        sensing zone and/or the third zone. The third criteria may be        comprised in the leakage criterion wherein when the third        criteria are met, the leakage criterion is met.

Parameter data (e.g. the first parameter data, the second parameterdata, the third parameter data) may be indicative of a change inresistance between any two of the plurality of electrodes (wherein atleast one electrode acts as a ground electrode), such as a drop ordecrease in resistance between the two electrodes, which is indicativeof a conductive path between the electrodes created by presence offoreign conductive material, i.e. presence of fluid between theelectrodes (i.e. faecal material). The first parameter data may beindicative of a change in resistance between electrodes of the firstsensor, such as a drop or decrease in resistance between electrodes ofthe first sensor, which is indicative of a conductive path between theelectrodes created by presence of foreign conductive material, i.e.presence of fluid between the electrodes. The second parameter data maybe indicative of a change in resistance between electrodes of the secondsensor, such as a drop or decrease in resistance between electrodes ofthe second sensor, which is indicative of a conductive path between theelectrodes created by presence of foreign conductive material, i.e.presence of fluid between the electrodes. The third parameter data maybe indicative of a change in resistance between electrodes of the thirdsensor, such as a drop or decrease in resistance between electrodes ofthe first sensor, which is indicative of a conductive path between theelectrodes created by presence of foreign conductive material, i.e.presence of fluid between the electrodes. The fourth parameter data maybe indicative of a change in resistance between electrodes of the fourthsensor, such as a drop or decrease in resistance between electrodes ofthe fourth sensor, which is indicative of a conductive path between theelectrodes created by presence of foreign conductive material, i.e.presence of fluid between the electrodes.

In one or more exemplary methods, the method comprises: determiningwhether the leakage state fulfils a leakage criterion indicative of highrisk (risk of skin damage, of leakage beyond the surface of the baseplate and into clothes), and performing the step of communicating theleakage state when the leakage state fulfils a leakage criterion.

In one or more exemplary methods, determining one or more moisturepattern types based on the monitor data comprises identifying a moisturepattern type based on parameter data, such as for the correspondingzone, such as first parameter data. In one or more exemplary methods,determining one or more moisture pattern types comprises determining amoisture pattern type if a leakage criterion is fulfilled. The leakagecriterion may be based on the first parameter data, the second parameterdata and/or the third parameter data. The leakage criterion may befulfilled if parameter data changes, e.g. if a change in parameter datais larger than a leakage threshold. Thus, the moisture pattern typedetermination may be conditional on a change in the parameter data, inturn leading to an optimum use of power or battery resources in theostomy monitor device, and in timely communication to the user via theinterface.

In one or more exemplary methods, determining one or more moisturepattern types based on the monitor data comprises comparing firstparameter data, second parameter data, and third parameter data. In oneor more exemplary methods, determining one or more moisture patterntypes based on the monitor data comprises identifying a moisture patterntype based on the comparison. For example, an exemplary criterion, suchas one or more of a first criterion (of the first criteria), a secondcriterion (of the second criteria) and a third criterion (of the thirdcriteria), may be based on a difference and/or deviation rate betweenparameter data and/or parameters derived from parameter data. Forexample, determining a moisture pattern comprises determining a firsttertiary parameter, also denoted P_1_3, indicative of a time delaybetween changes in the first parameter data and the second parameterdata, such as a time delay between the first parameter data reaching (orbeing below) a first threshold and the second parameter data reaching(or being below) a second threshold. A high time delay (e.g. leakagecriterion: P_1_3>TH_D_1) may be indicative of leakage of faecal material(and thus high risk of skin damage), while a low time delay(P_1_3<TH_D_1) may be indicative of the ostomate perspiring or sweating.One or more criteria may be based on the first tertiary parameter. Forexample, determining a moisture pattern comprises determining a thirdtertiary parameter, also denoted P_3_3, indicative of a time delaybetween changes in the third parameter data and the fourth parameterdata, such as a time delay between the third parameter data reaching (orbeing below) a third threshold and the fourth parameter data reaching(or being below) a fourth threshold. A high time delay (e.g. leakagecriterion: P_3_3>TH_D_3) may be indicative of leakage of faecal material(and thus high risk of skin damage), while a low time delay(P_3_3<TH_D_1) may be indicative of the ostomate perspiring or sweating.One or more criteria may be based on the third tertiary parameter.

In one or more exemplary methods, the interface comprises an audiointerface, a visual interface, and/or a transceiver module.

In one or more exemplary methods, communicating the leakage state of theostomy appliance comprises displaying, on a visual interface (e.g. adisplay) of the accessory device, a user interface comprising a userinterface object representative of the leakage state, such as a firstuser interface object representative of a first leakage state, a seconduser interface object representative of a second leakage state, and/or athird user interface object representative of a third leakage state. Theuser interface object may be representative of one or more moisturepattern types determined, such as a first moisture pattern type, asecond moisture pattern type, and/or a third moisture pattern type.

In one or more exemplary methods, the user interface objectrepresentative of the leakage state comprises one or more of a firstuser interface object, and a second user interface object, wherein thefirst and/or second user interface objects are indicative of one or moreof a first leakage state, a second leakage state and a third leakagestate. For example, the user interface object may comprise one or morevisual indicators representative of the leakage state, such as a firstvisual indicator, a second visual indicator, a third visual indicator.For example, the visual indicator may be in a shape of two or moreconcentric rings indicating one or more of: the moisture pattern type,severity, imminence, and/position of the presence of fluid in the baseplate, such as the moisture pattern type. For example, two or moreconcentric rings may be arranged to surround a central circlerepresentative of the stomal opening of the base plate. For example, thetwo or more concentric rings around the central circle may visuallychange to reflect the moisture pattern type, severity, imminence, and/orposition of the presence of fluid in the base plate, such as themoisture pattern type. The visual change may be performed by a change ofone or more of: colour, shape, blurring, and animation. For example, thetwo or more concentric rings may be arranged so as to be split into aplurality of angular visual indicators, wherein an angular visualindicator is indicative of the angular position of the presence offluid, such as the moisture pattern type on the base plate. For example,the visual indicators may be a text prompt indicating to the user thedynamic internal leakage state of the ostomy appliance.

In one or more exemplary methods, communicating the leakage state of theostomy appliance comprises notifying the user via the interface, such asby displaying a notification on a display of the accessory device. Thenotification may comprise the user interface object representative ofthe leakage state. The notification may comprise a notificationindicator to open an application related to the ostomy appliance. Themethod may comprise detecting an input on the notification indicator, inresponse to the input, opening the application related to the ostomyappliance, and in response to the opening of the application, displayingthe leakage state on the visual interface.

In one or more exemplary methods, the ostomy system comprises a serverdevice. In one or more exemplary methods, communicating the leakagestate of the ostomy appliance comprises communicating the leakage stateof the ostomy appliance to the server device. For example, communicatingthe leakage state of the ostomy appliance to the server device maycomprise transmitting a message comprising the leakage state to theserver device from the accessory device.

The present disclosure provides an accessory device, the accessorydevice forms part of an ostomy system. The accessory device comprises amemory; a processor coupled to the memory; and an interface, coupled tothe processor. The interface is configured to communicate with one ormore devices of the ostomy system. The one or more devices comprising amonitor device, and/or an ostomy appliance configured to be placed on askin surface of a user or on any additional seals. The interface isconfigured to obtain monitor data from the one or more devices, such asto receive or retrieve the monitor data from the one or more devices.The monitor data may be indicative of a presence of fluid at a proximalside (or proximal surface) of a layer, such as a first adhesive layer ofthe ostomy appliance that is directed towards the skin surface, such asa first adhesive layer of a base plate of the ostomy appliance.

The processor may be configured to determine a leakage state of theostomy appliance based on the monitor data obtained. The leakage statemay be indicative of the dynamic internal state of the ostomy appliance(for example early presence of fluid that is not visible to the userwhen the ostomy appliance is worn), related to the leakage of output(e.g. faecal material), such as severity, imminence, timing of leakageat a proximal side of the ostomy appliance. Presence of fluid on theproximal side (or proximal surface) of the first adhesive layer mayaffect the adhesive performance of the ostomy appliance. The processormay be configured to determine the leakage state by determining amoisture pattern type as provided in the method disclosed herein. Themoisture pattern type may be based on one or more, such as all, of firstmonitor data, second monitor data, and third monitor data, such as firstparameter data, second parameter data and the third parameter data. Themoisture pattern type may be based on the fourth parameter data. Forexample, the leakage state is indicative of adhesive failure of the baseplate and/or leakage risk of the ostomy appliance and/or indicative ofthe risk of skin damage to the user of the ostomy system.

In one or more exemplary accessory devices, determination of a moisturepattern type may comprise selecting a moisture pattern type from a setof predefined moisture pattern types. The set of predefined moisturepattern types may comprise a number K of moisture pattern types, such asat least three moisture pattern types, at least four moisture patterntypes, at least five moisture pattern types. The number K of moisturepattern types may be in the range from four to twenty.

The memory may be configured to store the monitor data and/or theleakage state.

The interface is configured to communicate the leakage state of theostomy appliance to the user via the interface, such as an audiointerface, a visual interface, and/or a transceiver module. An audiointerface comprises for example a loudspeaker, and/or a microphone. Avisual interface comprises for example a display. A transceiver modulecomprises for example an antenna and/or a radio transceiver.

In one or more accessory devices, the interface is configured tocommunicate the leakage state of the ostomy appliance by displaying, ona visual interface (e.g. a display) of the accessory device, a userinterface comprising a user interface object representative of theleakage state, such as a first user interface object representative of afirst leakage state, a second user interface object representative of asecond leakage state, and/or a third user interface objectrepresentative of a third leakage state. The user interface object maybe representative of one or more moisture pattern types determined, suchas a first moisture pattern type, a second moisture pattern type, and/ora third moisture pattern type. In one or more accessory devices, theuser interface object representative of the leakage state comprises oneor more of a first user interface object, and a second user interfaceobject, wherein the first and/or second user interface objects areindicative of one or more of a first leakage state in a primary sensingzone and/or a first zone, a second leakage state in a secondary sensingzone and/or a second zone and a third leakage state in a tertiarysensing zone and/or a third zone. For example, the user interface objectmay comprise one or more visual indicators representative of the leakagestate, such as a first visual indicator for the first leakage state, asecond visual indicator for the second leakage state, a third visualindicator for the third leakage state.

The processor may be configured to instruct the interface to display auser interface a first user interface object representative of a firstleakage state based on the determination of the moisture pattern type.For example, when the moisture pattern type is determined, by theaccessory device, to be indicative of a first moisture pattern type (asdisclosed herein) and thereby the leakage state is determined by theaccessory device to indicate to change NOW the ostomy appliance, theaccessory device provides a user interface with a first user interfaceobject reflecting the leakage state of the corresponding sensing zone orzone and the first moisture pattern type of the corresponding zone ofthe base plate by adapting the visual appearance of the first userinterface object, e.g. in terms of colour, shade, and/or contrast.

The accessory device may comprise a user application configured tocommunicate the leakage state via the interface. The user applicationmay be a dedicated ostomy application that assist the user in monitoringthe internal leakage state of the ostomy appliance, and thereby reducethe likelihood of severe leakage reaching out to clothing of the user.

The present disclosure provides an ostomy appliance system comprising anostomy appliance, an accessory device and a monitor device, the ostomyappliance comprising a base plate. The accessory device is configured toperform any of the methods disclosed herein.

The present disclosure provides a computer readable storage mediumstoring one or more programs, the one or more programs comprisinginstructions, which when executed by an accessory device with aninterface, a memory and a processor cause the accessory device toperform any of the methods disclosed herein.

FIG. 1 illustrates an exemplary ostomy system. The ostomy system 1comprises an ostomy appliance 2 including a base plate 4 and an ostomypouch (not shown). Further, the ostomy system 1 comprises a monitordevice 6 and an accessory device 8 (mobile device). The monitor device 6is connectable to the base plate 4 via respective first connectors ofthe monitor device 6 and base plate 4. The monitor device 6 isconfigured for wireless communication with the accessory device 8.Optionally, the accessory device 8 is configured to communicate with aserver device 10 of the ostomy system 1, e.g. via network 12. The serverdevice 10 may be operated and/or controlled by the ostomy appliancemanufacturer and/or a service centre. Ostomy data or parameter databased on the ostomy data are obtained from electrodes/sensors of theostomy appliance 2 with the monitor device 6. The monitor device 6processes the ostomy data and/or parameter data based on the ostomy datato determine monitor data that are transmitted to the accessory device8. In the illustrated ostomy system, the accessory device 8 is a mobilephone, however the accessory device 8 may be embodied as anotherhandheld device, such as a tablet device, or a wearable, such as a watchor other wrist-worn electronic device. Accordingly, the monitor device 6is configured to determine and transmit monitor data to the accessorydevice 8. The base plate 4 comprises a coupling member 14 in the form ofa coupling ring 16 for coupling an ostomy pouch (not shown) to the baseplate (two-part ostomy appliance). The base plate has a stoma-receivingopening 18 with a stoma center point. The size and/or shape of thestomal opening 18 is typically adjusted by the user or nurse beforeapplication of the ostomy appliance to accommodate the user's stoma.

The ostomy system 1 optionally comprises a docking station 20 forming anaccessory device of the ostomy system 1. The docking station 20comprises a docking monitor interface including a first connector 22configured for electrically and/or mechanically connecting the monitordevice 6 to the docking station 20. The docking monitor interface may beconfigured for wirelessly connecting the monitor device to the dockingstation. The docking station 20 comprises a user interface 24 forreceiving user input and/or providing feedback to the user on theoperational state of the docking station 20. The user interface 24 maycomprise a touch-screen. The user interface 24 may comprise one or morephysical buttons and/or one or more visual indicators, such as lightemitting diodes.

FIG. 2 is a schematic block diagram of an exemplary monitor device. Themonitor device 6 comprises a monitor device housing 100, 101 and one ormore interfaces, the one or more interfaces including a first interface102 (appliance interface) and a second interface 104 (accessoryinterface). The monitor device 6 comprises a memory 106 for storingostomy data and/or parameter data based on the ostomy data. The memory106 is connected to the processor 101 and/or the first interface 102.

The first interface 102 is configured as an appliance interface forelectrically and/or mechanically connecting the monitor device 6 to theostomy appliance, e.g. ostomy appliance 2. The first interface 102comprises a plurality of terminals for forming electrical connectionswith respective terminals of the ostomy appliance 2 (base plate 4). Thefirst interface 102 comprises a ground terminal 108, a first terminal110, a second terminal 112 and a third terminal 114. The first interface102 optionally comprises a fourth terminal 116 and a fifth terminal 118.The first interface 102 of the monitor device 6 comprises a couplingpart 120 for forming a mechanical connection, such as a releasablecoupling between the monitor device and the base plate. The couplingpart 120 and the terminals 108, 110, 112, 114, 116, and 118 of the firstinterface 102 form (at least part of) a first connector of the monitordevice 6.

The monitor device 6 comprises a power unit 121 for powering the monitordevice and active components thereof, i.e. the power unit 121 isconnected to the processor 101, the first interface 102, the secondinterface 104, and memory 106. The power unit comprises a battery andcharging circuitry. The charging circuitry is connected to the batteryand terminals of the first interface 102 for charging the battery viaterminals of the first interface, e.g. terminals of the first connector.

The second interface 104 of monitor device is configured as an accessoryinterface for connecting the monitor device 6 to one or more accessorydevices such as accessory device 8. The second interface 104 comprisesan antenna 122 and a wireless transceiver 124 configured for wirelesscommunication with accessory device(s). Optionally, the second interface104 comprises a loudspeaker 126 and/or a haptic feedback element 128 forprovision of respective audio signal and/or haptic feedback to the user.

The monitor device 6 comprises a sensor unit 140 connected to theprocessor 101. The sensor unit 140 comprises a temperature sensor forfeeding temperature data to the processor and a G-sensor oraccelerometer for feeding acceleration data to the processor 101.

The processor 101 is configured to apply a processing scheme, and thefirst interface 102 is configured for collecting ostomy data from thebase plate coupled to the first interface, the ostomy data comprisingfirst ostomy data from a first electrode pair of the base plate, secondostomy data from a second electrode pair of the base plate, and thirdostomy data from a third electrode pair of the base plate. The ostomydata may be stored in the memory 106 and/or processed in the processor101 in order to obtain parameter data. The parameter data may be storedin the memory 106. The processor 101 is configured to apply a processingscheme, wherein to apply a processing scheme comprises obtain firstparameter data based on the first ostomy data; obtain second parameterdata based on the second ostomy data; obtain third parameter data basedon the third ostomy data. In other words, the processor 101 isconfigured to obtain first, second and third parameter data based onrespective first, second and third ostomy data. To apply a processingscheme comprises to determine an operating state of the base plate ofthe ostomy appliance based on one or more, e.g. all, of the firstparameter data, the second parameter data and the third parameter data,wherein the operating state is indicative of a degree of radial erosionof the base plate and/or acute leakage risk for the ostomy appliance.The monitor device 6 is configured to, in accordance with adetermination that the operating state is a first operating state,transmit a first monitor signal comprising monitor data indicative ofthe first operating state of the base plate via the second interface;and in accordance with a determination that the operating state is asecond operating state, transmit a second monitor signal comprisingmonitor data indicative of the second operating state of the base platevia the second interface.

FIG. 3 illustrates an exploded view of an exemplary base plate of anostomy appliance. The base plate 4 comprises a first adhesive layer 200.During use, a proximal surface of the first adhesive layer 200 adheresto the user's skin in the peristomal area and/or to additional seals,such as sealing paste, sealing tape and/or sealing ring. The base plate4 optionally comprises a second adhesive layer 202, also denoted rimadhesive layer. The base plate 4 comprises a plurality of electrodesarranged in an electrode assembly 204. The electrode assembly 204 isarranged between the first adhesive layer 200 and the second adhesivelayer 202. The electrode assembly 204 comprises a support layer withelectrodes formed on a proximal surface of the support layer. The baseplate 4 comprises a release liner 206 that is peeled off by the userprior to applying the base plate 4 on the skin. The base plate 4comprises a top layer 208 and a coupling ring 209 for coupling an ostomypouch to the base plate 4. The top layer 208 is a protective layerprotecting the second adhesive layer 202 from external strains andstress during use.

The base plate 4 comprises a monitor interface. The monitor interface isconfigured for electrically and/or mechanically connecting the ostomyappliance (base plate 4) to the monitor device. The monitor interface ofthe base plate comprises a coupling part 210 for forming a mechanicalconnection, such as a releasable coupling between the monitor device andthe base plate. The coupling part 210 is configured to engage with acoupling part of the monitor device for releasably coupling the monitordevice to the base plate 4. Further, the monitor interface of the baseplate 4 comprises a plurality of terminal elements respectively forminga plurality of terminals 212 for forming electrical connections withrespective terminals of the monitor device. The coupling part 210 andthe terminals 212 form a first connector 211 of the base plate 4. Thebase plate 4 comprises a first intermediate element 213 on the distalside of the electrode assembly. The first intermediate element 213 isarranged between the terminal elements forming terminals 212 and thefirst adhesive layer (not shown). The first intermediate element 213covers the terminal elements forming terminals 212 of the base plate 4when seen in the axial direction and protects the first adhesive layerfrom mechanical stress from the terminal elements of the base plate.

FIG. 4 illustrates an exploded view of an exemplary electrode assembly204 of a base plate. The electrode assembly 204 comprises a supportlayer 214 with proximal surface 214B and electrodes 216 arranged on theproximal side of the support layer 214 and including a ground electrode,a first electrode, a second electrode, a third electrode, a fourthelectrode, and a fifth electrode, wherein each electrode has arespective connection part for connecting the electrodes to respectiveterminal elements of the monitor interface. Further, electrode assembly204 comprises a masking element 218 with proximal surface 218B andconfigured to insulate electrode parts of electrodes 216 from the firstadhesive layer of the base plate. The masking element 218 covers oroverlap with parts of the electrodes 216 when seen in the axialdirection.

FIG. 5 is a proximal view of proximal surfaces of base plate parts ofthe base plate without the first adhesive layer and the release liner.The base plate 4 comprises a first intermediate element 213 on thedistal side of the electrode assembly, i.e. between the electrodeassembly 204 and the first adhesive layer (not shown). The firstintermediate element 213 covers the terminal elements of the base plate4 when seen in the axial direction and protects the first adhesive layerfrom mechanical stress from the terminal elements of the base plate.

FIG. 6 is a distal view of an exemplary electrode configuration 220 ofelectrodes 216 of the electrode assembly 204. The electrodeconfiguration 220/electrode assembly 204 comprises a ground electrode222, a first electrode 224, a second electrode 226, a third electrode228, a fourth electrode 230, and a fifth electrode 232. The groundelectrode 222 comprises a ground connection part 222A and the firstelectrode 224 comprises a first connection part 224A. The secondelectrode 226 comprises a second connection part 226A and the thirdelectrode 228 comprises a third connection part 228A. The fourthelectrode 230 comprises a fourth connection part 230A and the fifthelectrode 232 comprise a fifth connection part 232A.

The fourth electrode 230 comprises fourth sensing parts 230B. The fifthelectrode 232 comprises fifth sensing parts 232B.

The ground electrode 222 comprises a first electrode part 224 forforming a ground for the first electrode 224. The ground electrode 222comprises a second electrode part 236 for forming a ground for thesecond electrode 226. The ground electrode 222 comprises a thirdelectrode part 238 for forming a ground for the third electrode 228. Theground electrode 222 comprises a fourth electrode part 240 for forming aground for the fourth electrode 230 and the fifth electrode 232. Thefourth electrode part 240 of the ground electrode 222 comprises groundsensing parts 222B

FIG. 7 is a distal view of an exemplary masking element. The maskingelement 218 optionally has a plurality of terminal openings includingsix terminal openings. The plurality of terminal openings comprises aground terminal opening 242, a first terminal opening 244, a secondterminal opening 246, a third terminal opening 248, a fourth terminalopening 250, and a fifth terminal opening 252. The terminal openings242, 244, 246, 248, 250, 252 of the masking element 218 are configuredto overlap and/or be aligned with respective connection parts 222A,224A, 226A, 228A, 230A, 232A of the electrodes of the electrodeassembly.

The masking element 218 has a plurality of sensor point openings. Thesensor point openings comprise primary sensor point openings shownwithin dotted line 254, each primary sensor point opening configured tooverlap a part of the ground electrode 222 and/or a part of the fourthelectrode 230. The primary sensor point openings 254 comprise, in theillustrated exemplary masking element, five primary first sensor pointopenings 254A each configured to overlap a part of the ground electrode222. The primary sensor point openings 254 comprise, in the illustratedexemplary masking element, four primary second sensor point openings254B each configured to overlap a part of the fourth electrode 230. Thesensor point openings comprise secondary sensor point openings shownwithin dotted line 256, each second sensor point opening configured tooverlap a part of the fourth electrode 230 and/or a part of the fifthelectrode 232. The secondary sensor point openings 256 comprise, in theillustrated exemplary masking element, five secondary first sensor pointopenings 256A each configured to overlap a part of the fifth electrode232. The secondary sensor point openings 256 comprise, in theillustrated exemplary masking element, four secondary second sensorpoint openings 256B each configured to overlap a part of the fourthelectrode 230. The sensor point openings comprise tertiary sensor pointopenings shown within dotted line 258, each tertiary sensor openingconfigured to overlap a part of the fifth electrode 232 and/or a part ofthe ground electrode 222. The tertiary sensor point openings 258comprise, in the illustrated exemplary masking element, five tertiaryfirst sensor point openings 258A each configured to overlap a part ofthe fifth electrode 232. The tertiary sensor point openings 258comprise, in the illustrated exemplary masking element, four tertiarysecond sensor point openings 258B each configured to overlap a part ofthe ground electrode 222.

FIG. 8 is a distal view of an exemplary first adhesive layer. The firstadhesive layer 200 has a plurality of sensor point openings. The sensorpoint openings of the first adhesive layer comprise primary sensor pointopenings shown within dotted line 260, each primary sensor point openingconfigured to overlap a part of the ground electrode 222 and/or a partof the fourth electrode 230 of the electrode assembly. The primarysensor point openings 260 comprise, in the illustrated exemplary firstadhesive layer, five primary first sensor point openings 260A eachconfigured to overlap a part of the ground electrode 222. The primarysensor point openings 260 comprise, in the illustrated exemplary firstadhesive layer, four primary second sensor point openings 260B eachconfigured to overlap a part of the fourth electrode 230. The sensorpoint openings of the first adhesive layer comprise secondary sensorpoint openings shown within dotted line 262, each second sensor pointopening configured to overlap a part of the fourth electrode 230 and/ora part of the fifth electrode 232 of the electrode assembly. Thesecondary sensor point openings 262 comprise, in the illustratedexemplary first adhesive layer, five secondary first sensor pointopenings 262A each configured to overlap a part of the fifth electrode232. The secondary sensor point openings 262 comprise, in theillustrated exemplary first adhesive layer, four secondary second sensorpoint openings 262B each configured to overlap a part of the fourthelectrode 230.The sensor point openings of the first adhesive layercomprise tertiary sensor point openings shown within dotted line 264,each tertiary sensor opening configured to overlap a part of the fifthelectrode 232 and/or a part of the ground electrode 222 of the electrodeassembly. The tertiary sensor point openings 264 comprise, in theillustrated exemplary first adhesive layer, five tertiary first sensorpoint openings 264A each configured to overlap a part of the fifthelectrode 232. The tertiary sensor point openings 264 comprise, in theillustrated exemplary first adhesive layer, four tertiary second sensorpoint openings 264B each configured to overlap a part of the groundelectrode 222. FIG. 9 is a proximal view of the first adhesive layer ofFIG. 8.

FIG. 10 is a more detailed distal view of a part of the base plate 4.Monitor interface of the base plate comprises the first connector 211.The first connector 211 comprises coupling part 210 configured toreleasably couple the monitor device to the base plate and thus forminga releasable coupling. The first connector 221/monitor interfacecomprises a plurality of terminals formed by respective terminalelements for forming respective electrical connections with respectiveterminals of the monitor device.

The plurality of terminals of the first connector 211/monitor interfacecomprises a ground terminal element 282 forming a ground terminal 282A,a first terminal element 284 forming a first terminal 284, a secondterminal element 286 forming a second terminal 286A, and a thirdterminal element 288 forming a third terminal 288A. The monitorinterface optionally comprises a fourth terminal element 290 forming afourth terminal 290A and/or a fifth terminal element 292 forming a fifthterminal 290. The terminal elements 282, 284, 286, 288, 290, 292 contactrespective connection parts 222A, 224A, 226A, 228A, 230 a, 232A ofelectrodes 222, 224, 226, 228, 230, 232.

The position of the first connector on the base plate, the number ofterminals and the position of the terminals in the coupling part may beadapted to the electrode configuration used in the electrode assembly ofthe base plate.

FIG. 11 illustrates an exemplary method 300 of communicating the leakagestate according to the present disclosure. The method 300 is performedin an accessory device, for communicating the leakage state of theostomy appliance, which in turn enables a monitoring leakage of theostomy appliance at the accessory device. The accessory device comprisesan interface configured to communicate with one or more devices of anostomy system. The one or more devices comprise a monitor device, and/oran ostomy appliance configured to be placed on a skin surface of a useror on any additional seals.

The method 300 comprises obtaining 301 (e.g. receiving and/orretrieving) monitor data from the one or more devices. The monitor datais indicative of a presence of fluid of the ostomy appliance.

In one or more exemplary methods, the method 300 may comprisedetermining 302 a leakage state of the ostomy appliance based on themonitor data. A leakage state in the present disclosure is indicative ofthe dynamic internal state of the ostomy appliance, related to thepresence of fluid (e.g. output, and/or feces) at the proximal side (orproximal surface) of the first adhesive layer of the ostomy appliance(between the skin surface and the proximal surface of the first adhesivelayer) which is not visible to the user when the ostomy appliance isused. The leakage state may be indicative of adhesive performance of theostomy appliance. The leakage state may be affected by several factorssuch as humidity, temperature, misplacement of the ostomy appliance onthe stoma, and/or malfunction of the ostomy appliance and/or related tomisplacement of the ostomy appliance on the stoma, and/or malfunction ofthe ostomy appliance. One or more factors alone or in combination impactthe leakage state of the ostomy appliance. A leakage state in thepresent disclosure is configured to indicate whether the ostomyappliance needs to be changed based on its leakage state. For example,the leakage state may be indicative of the severity and/or imminence ofthe severe leakage, and thereby of the severity and/or imminence of therequired change. The leakage state may comprise N leakage states, whereN is an integer. For example, the leakage state may comprise a firstleakage state for a first zone and/or a primary sensing zone. A firstleakage state may comprise a first primary leakage state, a firstsecondary leakage state, a first tertiary leakage state (e.g. check,change in X time, change NOW, no leakage,).

The method comprises communicating 303 the leakage state of the ostomyappliance via the interface to the user or to the one or more devices.Communication 303 may comprise outputting, transmitting and/ordisplaying the leakage state determined. In one or more exemplarymethods, the method comprises determining 304 whether the leakage statefulfils a leakage criterion indicative of high risk (e.g. a severeleakage), and performing the step of communicating 303 the leakage statewhen the leakage state fulfils the leakage criterion. There may beseveral criteria, such as first criteria, second criteria, thirdcriteria.

In one or more exemplary methods, the ostomy appliance comprises anostomy pouch and a base plate. In one or more exemplary methods, thebase plate comprises a first adhesive layer having a proximal side (orproximal surface). In one or more exemplary methods, obtaining 301 themonitor data comprises obtaining 301 a the monitor data indicative ofthe presence of fluid at the proximal side (or proximal surface) of thefirst adhesive layer of the base plate. The presence of fluid at theproximal side of the first adhesive layer creates a conductive path inthe proximal surface of the first adhesive layer.

In one or more exemplary methods, the base plate comprises a pluralityof electrodes configured to detect presence of fluid on the proximalside in a primary sensing zone (and/or a first zone) and a secondarysensing zone (and/or a second zone). The plurality of electrodes mayinclude a first leakage electrode, a second leakage electrode, and athird leakage electrode. The first leakage electrode may serve as aground electrode. The second leakage electrode may serve as the fourthelectrode of the base plate embodiment disclosed herein. The thirdleakage electrode may serve as the fifth electrode of the base plateembodiment disclosed herein. The plurality of electrodes may include afirst electrode, a second electrode, and a third electrode of the baseplate embodiment disclosed herein. The In one or more exemplary methods,obtaining 301 monitor data comprises obtaining 301 b data representativeof detection of fluid on the proximal side (or proximal surface) in theprimary sensing zone (and/or first zone) and the secondary sensing zone(and/or second zone).

In one or more exemplary methods, the monitor data comprises ostomy dataand/or parameter data. For example, the parameter data is derived basedon ostomy data. In one or more exemplary methods, obtaining 301 monitordata comprises obtaining ostomy data and/or parameter data. In one ormore exemplary methods, obtaining 301 monitor data comprises obtainingthe ostomy data and/or parameter data indicative of resistance betweenany two electrodes of the plurality of electrodes wherein at least oneof the electrodes is a ground electrode, capacitance and/or inductancebetween electrodes between any two electrodes of the plurality ofelectrodes wherein at least one of the electrodes is a ground electrodeand/or any change thereof. In one or more exemplary methods, the ostomydata and/or parameter data are indicative of a change in resistance,capacitance and/or inductance between any two electrodes of theplurality of electrodes wherein at least one of the electrodes is aground electrode. In one or more exemplary methods, obtaining 301monitor data comprises obtaining the ostomy data and/or parameter datacomprising timing information, for e.g. a first primary sensing zone(and/or first zone), and optionally a second primary sensing zone(and/or second zone), such as timestamped data or information from whichtiming is derivable, for e.g. a first primary sensing zone (and/or firstzone), and optionally a second primary sensing zone (and/or secondzone).

In one or more exemplary methods, the monitor data comprises localizedmonitor data with respect to a location and/or zone on the base plate.The sensing zone and/or zone on the proximal side of the first adhesivelayer of the base place may be related to a zone where the parameterdata shows a drop or decrease in the resistance between two electrodes.In one or more exemplary methods, obtaining 301 the monitor datacomprises obtaining 301 c (e.g. receiving from one or more devices inthe ostomy system, and/or retrieving from one or more devices in theostomy system) localized monitor data with respect to a location and/orzone of the base plate, e.g. at the proximal side (e.g. proximalsurface) of the first adhesive layer of the base plate. In one or moreexemplary methods, the localized monitor data may be with respect to theprimary sensing zone, the secondary sensing zone, and/or a tertiarysensing zone. In one or more exemplary methods, the monitor data maycomprise first localized monitor data indicative of presence of fluid atthe first zone, second localized monitor data indicative of presence offluid at the second zone.

In one or more exemplary methods, determining 302 the leakage state ofthe ostomy appliance based on the monitor data comprises determining 302a the leakage location, and/or the leakage timing.

In one or more exemplary methods, determining 302 the leakage state ofthe ostomy appliance based on the monitor data comprises determining 302b one or more moisture pattern types based on the monitor data, such asbased on the ostomy data and/or the parameter data (e.g. first parameterdata and second parameter data by the leakage electrodes, such asindicating a drop or decrease in f resistance, capacitance and/orinductance satisfying a leakage criteria. The moisture pattern type isoptionally indicative of adhesive failure of the base plate and/orleakage risk of the ostomy appliance and/or indicative of the risk ofskin damage to the user of the ostomy system. In one or more exemplarymethods, determining 302 the leakage state of the ostomy appliance basedon the monitor data comprises determining one or more moisture patterntypes based on the first parameter data and second parameter data (andoptionally a third parameter) wherein the first parameter data isindicative of presence of fluid in the primary sensing zone (and/orfirst zone), and the second parameter data is indicative of presence offluid in the secondary sensing zone (and/or second zone).

In one or more exemplary methods, determining 302 b one or more moisturepattern types may comprise selecting a moisture pattern type from a setof predefined moisture pattern types. The set of predefined moisturepattern types may comprise a number K of moisture pattern types, such asat least three moisture pattern types, at least four moisture patterntypes, at least five moisture pattern types. The number K of moisturepattern types may be in the range from four to twenty.

In one or more exemplary methods determining 302 b one or more moisturepattern types may comprise identifying 302 bb the moisture pattern typebased on the determination.

In one or more exemplary methods, determining 302 the leakage state ofthe ostomy appliance based on the monitor data comprises deriving 302 cthe leakage state based on the one or more moisture pattern types, suchas a first moisture pattern type, a second moisture pattern type, and/ora third moisture pattern type, such as based on first parameter dataindicative of presence of fluid in the primary sensing zone or in thefirst zone, second parameter data indicative of presence of fluid in thesecondary sensing zone or in the second zone, and optionally thirdparameter data indicative of presence of fluid in the tertiary sensingzone or in the third zone.

In one or more exemplary methods, communicating 303 the leakage state ofthe ostomy appliance comprises displaying 303 a, on a visual interface(e.g. a display) of the accessory device, a user interface comprising auser interface object representative of the leakage state, such as afirst user interface object representative of a first leakage state inthe primary sensing zone (and/or first zone), a second user interfaceobject representative of a second leakage state in the secondary sensingzone (and/or second zone), and/or a third user interface objectrepresentative of a third leakage state in the tertiary sensing zone(and/or third zone). The first leakage state may comprise a firstprimary leakage state, a first secondary leakage state, a first tertiaryleakage state (e.g. change NOW, check, change in X time, no leakage).The second leakage state may comprise a second primary leakage state, asecond secondary leakage state, a second tertiary leakage state and/or asecond quaternary leakage state (e.g. change NOW, check, change in Xtime, no leakage). The third leakage state may comprise a third primaryleakage state, a third secondary leakage state, a third tertiary leakagestate and/or a third quaternary leakage state (e.g. change NOW, check,change in X time, no leakage).

The user interface object may be representative of one or more moisturepattern types determined, such as a first moisture pattern type, asecond moisture pattern type, and/or a third moisture pattern type. Forexample, the user interface object may comprise one or more visualindicators representative of the leakage state, such as a first visualindicator, a second visual indicator, a third visual indicator.

In one or more exemplary methods, communicating 303 the leakage state ofthe ostomy appliance comprises notifying 303 b the user via theinterface, such as by displaying a notification on a display of theaccessory device. The notification may comprise the user interfaceobject representative of the leakage state. The notification maycomprise a notification indicator to open an application related to theostomy appliance. The method may comprise detecting an input on thenotification indicator, in response to the input, opening theapplication related to the ostomy appliance, and in response to theopening of the application, displaying the leakage state.

In one or more exemplary methods, the ostomy system comprises a serverdevice. In one or more exemplary methods, communicating 303 the leakagestate of the ostomy appliance comprises communicating 303 c the leakagestate of the ostomy appliance to the server device. For example,communication the leakage state of the ostomy appliance to the serverdevice may comprise transmitting a message comprising the leakage stateto the server device from the accessory device.

FIG. 12 is a block diagram illustrating an exemplary accessory device 8according to the present disclosure. The accessory device 8 forms partof an ostomy system and is capable of supporting the monitoring andcommunication of the leakage state of an ostomy appliance to be placedon a user' s skin. The accessory device 8 comprises a memory 401; aprocessor 402 coupled to the memory 401; and an interface 403 coupled tothe processor 402.

Peripheral devices 401, 403 can be operatively and communicably coupledto the processor 402 via a bus for communicating data. The processor 402can be a central processing unit (CPU), but other suitablemicroprocessors are also contemplated.

The interface 403 is configured to communicate with one or more devicesof the ostomy system. The one or more devices comprising a monitordevice, and/or an ostomy appliance configured to be placed on a skinsurface of a user or on any additional seals. The interface 403 isconfigured to obtain monitor data from the one or more devices, such asto receive or retrieve the monitor data from the one or more devices.The monitor data may be indicative of a presence of fluid at a proximalside of the first adhesive layer of the ostomy appliance, such as apresence of fluid of a proximal side of the first adhesive layer of abase plate of the ostomy appliance.

The processor 402 may be configured to determine a leakage state of theostomy appliance based on the monitor data obtained. The leakage stateis indicative of the dynamic internal state of the ostomy appliance (forexample early presence of fluid that is not visible to the user when theostomy appliance is worn), related to the leakage of output (e.g. faecalmaterial), such as severity, imminence, timing of leakage at a proximalside (or proximal surface) of the ostomy appliance. Presence of fluid onthe proximal side (or proximal surface) of the first adhesive layer mayaffect the adhesive performance of the ostomy appliance. The processor402 may be configured to determine the leakage state by determining amoisture pattern type. The moisture pattern type may be based on one ormore, such as all, of first monitor data, second monitor data, and thirdmonitor data, such as first parameter data, second parameter data andthe third parameter data. The moisture pattern type may be based on thefourth parameter data.

The processor 402 is configured to determine one or more moisturepattern types based on the monitor data by identifying a moisturepattern type based on parameter data, such as for the correspondingzone, such first parameter data. determining the leakage state of theostomy appliance based on the monitor data comprises deriving theleakage state based on the one or more moisture pattern types, such asderiving a first leakage state for a primary sensing zone (and/or firstzone) based on the first parameter data, deriving a second leakage statefor a secondary sensing zone (and/or second zone) based on secondparameter data, and/or deriving a third leakage state for a tertiarysensing zone (and/or third zone) based on third parameter data

In one or more exemplary accessory devices, determination of a moisturepattern type may comprise selecting a moisture pattern type from a setof predefined moisture pattern types. The set of predefined moisturepattern types may comprise a number K of moisture pattern types, such asat least three moisture pattern types, at least four moisture patterntypes, at least five moisture pattern types. The number K of moisturepattern types may be in the range from four to twenty.

The memory 401 may be configured to store the monitor data and/or theleakage state. The processor 402 may be configured to instruct theinterface 403 to display a user interface a first user interface objectrepresentative of a first leakage state based on the determination ofthe moisture pattern type. For example, when the moisture pattern typeis determined, by the processor 402, to be indicative of a firstmoisture pattern type (as disclosed herein) and thereby the leakagestate is determined by the processor 402 to indicate to change NOW theostomy appliance, the accessory device provides instructions to theinterface 403 to display a user interface with a first user interfaceobject reflecting the leakage state of the corresponding sensing zone orzone and the first moisture pattern type of the corresponding zone ofthe base plate by adapting the visual appearance of the first userinterface object, e.g. in terms of colour, shade, and/or contrast.

The interface 403 is configured to communicate the leakage state of theostomy appliance to the user via the interface, such as an audiointerface, a visual interface, and/or a transceiver module.

In one or more accessory devices, the interface 403 is configured tocommunicate the leakage state of the ostomy appliance by displaying, ona visual interface (e.g. a display) of the accessory device, a userinterface comprising a user interface object representative of theleakage state, such as a first user interface object representative of afirst leakage state, a second user interface object representative of asecond leakage state, and/or a third user interface objectrepresentative of a third leakage state. The user interface object maybe representative of one or more moisture pattern types determined, suchas a first moisture pattern type, a second moisture pattern type, and/ora third moisture pattern type. In one or more accessory devices, theuser interface object representative of the leakage state comprises oneor more of a first user interface object, and a second user interfaceobject, wherein the first and/or second user interface objects areindicative of one or more of a first leakage state, a second leakagestate and a third leakage state. For example, the user interface objectmay comprise one or more visual indicators representative of the leakagestate, such as a first visual indicator, a second visual indicator, athird visual indicator.

FIGS. 13a-c illustrate exemplary user interfaces for communicating theleakage state according to the present disclosure.

FIG. 13a shows an exemplary user interface 500 for communicating theleakage state of an ostomy appliance via an accessory device, such asvia a visual interface of the accessory device. The user interface 500comprises a plurality of visual indicators 502, 504, 506, 508, 522, 524,526. Visual indicators 502, 504, 506 have the shape of a ring. Visualindicator 508, 522, 524, 526 has the shape of a circle. The userinterface 500 comprises a central circle 508, a first circle 522, afirst ring 502, a second circle 524, a second ring 504, a third circle526, and a third ring 506. Each visual indicator 502, 504, 506, 508,522, 524, 526 is arranged at a radial distance from the center of thefirst circle 508. The first ring 502, the second ring 504, and the thirdring 506 are arranged concentrically around the first circle 508. It maybe seen that the user interface is representative of a base plate of anostomy appliance where the first circle 508 is representative of thestomal opening of the base plate and each of the first ring 502, thesecond ring 504, and the third ring 506 alone or in combination maydefine an area or a zone of the base plate.

The leakage state of the ostomy appliance is based on the moisturepattern type determined using parameter data obtained from one or moredevices, such as a monitor device coupled with the base plate havingelectrodes placed in respective zones of the base plate (such aselectrodes of FIG. 6 and/or sensor points openings of FIG. 7).

In one or more embodiments, the plurality of electrodes comprises afirst electrode, a second electrode, and a third electrode, wherein theplurality of electrodes is configured to detect presence of fluid on theproximal side (or proximal surface) in a first zone, a second zone, athird zone of the base plate. The first zone is at a first radialdistance from the center point of the stomal opening of the base plate.The second zone is at a second radial distance from the center point ofthe stomal opening of the base plate. The third zone is at a thirdradial distance from the center point of the stomal opening of the baseplate. The first ring 502 may be representative of a first zone. Thesecond ring 504 may be representative of a second zone. The third ring506 may be representative of a third zone.

The visual appearance of any of the visual indicators 502, 504, 506, 508may be configured to change dynamically based on the leakage state (e.g.degree of leakage state) of the ostomy appliance (i.e. so that thevisual indicator reflects the current leakage state of the ostomyappliance as determined by the accessory device based on the monitordata obtained). The visual appearance of any of the visual indicators502, 504, 506, 508 may be configured to change dynamically in terms ofcolour, shape, form, contrast, brightness, animation and/or blurring toindicate the leakage state. For example, the severity of the leakagestate may be displayed by varying in colour: e.g. blue, yellow, red forindicating low, medium, high severity (e.g. no leakage, or very low,low, high risk) respectively. For example, the severity of the leakagestate may be displayed by varying shades within a colour from a lightershade to a darker shade for indicating low to high severity (e.g. low tohigh risk) respectively. For example, the severity of the leakage statemay be displayed by varying a magnitude of the visual effect (e.g., moreblurring) as severity increases. For example, a (first, second, orthird) primary leakage state may be represented by a first visualappearance of the corresponding visual indicator, e.g. of thecorresponding ring. For example, a (first, second, or third) secondaryleakage state may be represented by a second visual appearance of thecorresponding visual indicator, e.g. of the corresponding ring. Forexample, a (first, second, or third) tertiary leakage state may berepresented by a third visual appearance of the corresponding visualindicator, e.g. of the corresponding ring. For example, a (first,second, or third) quaternary leakage state may be represented by afourth visual appearance of the corresponding visual indicator, e.g. ofthe corresponding ring. For example, a (first, second, or third) primaryleakage state is indicative of high risk (e.g. high severity and/or highimminence) of leakage e.g.: change NOW. For example, a (first, second,or third) secondary leakage state is indicative of low risk (e.g. lowseverity and/or low imminence) of leakage e.g.: check or change in Xtime. For example, a (first, second, or third) tertiary leakage state isindicative of very low risk (e.g. very low severity and/or very lowimminence of severe leakage) of leakage e.g.: check or change in X time.For example, a (first, second, or third) quaternary leakage state isindicative of no leakage (i.e. no presence of fluid on the proximalsurface of the first adhesive layer). It may be envisaged that thevisual appearance is selected based on risk level of the leakage state.

The accessory device is configured to change dynamically the visualappearance of any of the rings in terms of e.g. colour, shape, form,contrast, brightness, animation and/or blurring in accordance with theleakage state (so as to reflect the determined moisture pattern type).For example, when the moisture pattern type is determined, by theaccessory device, to be indicative of high severity (e.g. first moisturepattern type) and thereby the leakage state indicates to change NOW theostomy appliance, the accessory device provides a user interface 500with first ring 502 reflecting the leakage state derived from themonitor data indicating presence of fluid in the first zone andindicating the first moisture pattern type of the corresponding firstzone of the base plate by adopting e.g. the colour red, in a dark shade,in sharp contrast.

Additionally, or alternatively, when any of the leakage state isindicative of an acute leakage, corresponding to change NOW, any of thevisual indicators 502, 504, 506, 508 may be configured to be displayedwith a single visual appearance (such as a single colour, such as red)to indicate clearly and unambiguously that the leakage state is of highrisk and needs immediate attention.

As illustrated in FIG. 13b , in one or more exemplary user interfaces,the user interface 500 comprises a plurality of angular visualdelimiters (such as a first angular visual delimiter 512, a secondangular visual delimiter 514, a third angular visual delimiter 516). Theuser interface 500 comprises a first primary ring part 502 a, a firstsecondary ring part 502 b, a first tertiary ring part 502 c, a secondprimary ring part 506 a, a second secondary ring part 506 b, a secondtertiary ring part 506 c, a third primary ring part 506 a, a thirdsecondary ring part 506 b, and/or a third tertiary ring part 506 c.

It may be seen that the base plate comprises a plurality of electrodes,e.g. leakage electrodes, configured to detect presence of fluid on theproximal side (or proximal surface) in one or more primary sensing zones(represented by a first primary ring part 502 a, a second primary ringpart 504 a, a third primary ring part 506 a), one or more secondarysensing zones (such as a first secondary ring part 502 b, a secondsecondary ring part 504 b, a third secondary ring part 506 b), one ormore tertiary sensing zones (such as a first tertiary ring part 502 c, asecond tertiary ring part 504 c, a third tertiary ring part 506 c). Inone or more embodiments, the plurality of electrodes may include a firstleakage electrode, a second leakage electrode, and a third leakageelectrode, wherein any two of the leakage electrodes are configured todetect presence of fluid on the proximal side in a primary sensing zoneand a secondary sensing zone. The first leakage electrode may compriseone or more primary first sensing parts arranged in the primary sensingzone. The second leakage electrode may comprise one or more primarysecond sensing parts arranged in the primary sensing zone. The secondleakage electrode may comprise one or more secondary second sensingparts arranged in the secondary sensing zone (e.g. sensor point openingsof FIG. 7). The third leakage electrode may comprise one or moresecondary third sensing parts arranged in the secondary sensing zone(e.g. sensor point openings of FIG. 7). The primary sensing zone may bearranged in a primary angle space from the center point of the firstadhesive layer and the secondary sensing zone may be arranged in asecondary angle space from the center point of the first adhesive layer.The primary angle space may span a primary angle in the range from 45°to 315°. The secondary angle space may span a secondary angle in therange from 45° to 315°. The primary sensing zone and the secondarysensing zone may be separate sensing zones, such as non-overlappingsensing zones. The sensing parts may be place at equal distance from thecenter point.

It may be seen that the ring parts 502 a, 504 a, and 506 a form aprimary ring part that is arranged in a primary angle space from thecenter point of the first circle 508. It may be seen that the ring parts502 b, 504 b, and 506 b form a secondary ring part that is arranged in asecondary angle space from the center point of the first circle 508). Itmay be seen that the ring parts 502 c, 504 c, and 506 c form a tertiaryring part that is arranged in a tertiary angle space from the centerpoint of the first circle 508. The primary angle space may be arrangedto span a primary angle in the range from 45° to 315°. The secondaryangle space may be arranged to span a secondary angle in the range from45° to 315°. The tertiary angle space may be arranged to span a tertiaryangle in the range from 45° to 315°.

The accessory device of may be configured to change dynamically thevisual appearance of any of the ring parts, e.g. in terms of colour,shape, form, contrast, brightness, animation and/or blurring inaccordance with the leakage state, e.g. in accordance with determinationof the moisture pattern type. The accessory device is configured tochange dynamically the visual appearance of any of the ring parts interms of e.g. colour, shape, form, contrast, brightness, animationand/or blurring in accordance with the leakage state (so as to reflectthe determined moisture pattern type). For example, when the moisturepattern type is determined, by the accessory device, to be indicative ofhigh severity (e.g. first moisture pattern type) and thereby the leakagestate indicates to change NOW the ostomy appliance, the accessory deviceprovides a user interface 500 with first primary ring part 502 areflecting the leakage state of the corresponding primary sensing zoneand the first moisture pattern type of the corresponding primary sensingzone of the base plate by adopting e.g. the colour red, in a dark shade,in sharp contrast.

It may be seen that the first primary ring part 502 a, first secondaryring part 502 b, the first tertiary ring part 502 c are indicative ofthe leakage state of the first zone or the primary sensing zone, any ofwhich is represented by a first ring 502. The same applies to ring parts504 a, 504 b, 504 c forming part of second ring 504, and to ring parts506 a, 506 b, 506 c forming parts of third ring 506.

The monitor data may be seen as indicative of the leakage state of theostomy appliance. The visual appearance of the visual indicators isindicative of the leakage state of the ostomy appliance, such asindicative of the moisture pattern type determined by the accessorydevice.

As illustrated in FIG. 13c , in one or more exemplary user interfaces,the user interface 500 comprises a visual indicator which is a textprompt 510 indicating to the user the dynamic internal leakage state ofthe ostomy appliance. A text prompt 510 may for example indicate:“Everything is fine”, “Good”, “Check”, “Change”, “Change NOW”.

The accessory device may be configured to provide the user interface 500of FIG. 13a -c in a user application running on the processor. Theaccessory device may comprise a user application configured tocommunicate the leakage state via the interface. The user applicationmay be a dedicated ostomy application that assist the user in monitoringthe internal leakage state of the ostomy appliance, and thereby reducethe likelihood of severe leakage reaching out to clothing of the user.

The use of the terms “first”, “second”, “third” and “fourth”, “primary”,“secondary”, “tertiary” etc. does not imply any particular order, butare included to identify individual elements. Moreover, the use of theterms “first”, “second”, “third” and “fourth”, “primary”, “secondary”,“tertiary” etc. does not denote any order or importance, but rather theterms “first”, “second”, “third” and “fourth”, “primary”, “secondary”,“tertiary” etc. are used to distinguish one element from another. Notethat the words “first”, “second”, “third” and “fourth”, “primary”,“secondary”, “tertiary” etc. are used here and elsewhere for labellingpurposes only and are not intended to denote any specific spatial ortemporal ordering. Furthermore, the labelling of a first element doesnot imply the presence of a second element and vice versa.

Although particular features have been shown and described, it will beunderstood that they are not intended to limit the claimed invention,and it will be made obvious to those skilled in the art that variouschanges and modifications may be made without departing from the spiritand scope of the claimed invention. The specification and drawings are,accordingly to be regarded in an illustrative rather than restrictivesense. The claimed invention is intended to cover all alternatives,modifications and equivalents.

LIST OF REFERENCES

1 ostomy system

2 ostomy appliance

4 base plate

6 monitor device

8 accessory device

10 server device

12 network

14 coupling member

16 coupling ring

18 stoma-receiving opening

20 docking station

22 first connector

24 docking station user interface

100 monitor device housing

101 processor

102 first interface

104 second interface

106 memory

108 ground terminal of monitor device

110 first terminal of monitor device

112 second terminal of monitor device

114 third terminal of monitor device

116 fourth terminal of monitor device

118 fifth terminal of monitor device

120 coupling part

121 power unit

122 antenna

124 wireless transceiver

126 loudspeaker

128 haptic feedback element

140 sensor unit

200 first adhesive layer

200A distal surface of first adhesive layer

200B proximal surface of the first adhesive layer

202 second adhesive layer

202A distal surface of second adhesive layer

202B proximal surface of second adhesive layer

204 electrode assembly

204A distal surface of electrode assembly

204B proximal surface of electrode assembly

206 release liner

206A distal surface of the release liner

206B proximal surface of the release liner

208 top layer

208A distal surface of the top layer

208B proximal surface of the top layer

209 coupling ring

210 coupling part of first connector

211 first connector

212 terminals of first connector

213 first intermediate element

213A distal surface of first intermediate element

213B proximal surface of first intermediate element

214 support layer of electrode assembly

214A distal surface of support layer

214B proximal surface of support layer

216 electrodes of electrode assembly

218 masking element

218A distal surface of masking element

218B proximal surface of masking element

220 electrode configuration

222 ground electrode

222A ground connection part

222B ground sensing part

224 first electrode

224A first connection part

226 second electrode

226A second connection part

228 third electrode

228A third connection part

230 fourth electrode

230A fourth connection part

230B fourth sensing part

232 fifth electrode

232A fifth connection part

232B fifth sensing part

234 first electrode part of the ground electrode

236 second electrode part of the ground electrode

238 third electrode part of the ground electrode

240 fourth electrode part of the ground electrode

242 ground terminal opening

244 first terminal opening

246 second terminal opening

248 third terminal opening

250 fourth terminal opening

252 fifth terminal opening

254 primary sensor point openings of masking element

254A primary first sensor point opening

254B primary second sensor point opening

256 secondary sensor point openings of masking element

256A secondary first sensor point opening

256B secondary second sensor point opening

258 tertiary sensor point openings of masking element

258A tertiary first sensor point opening

258B tertiary second sensor point opening

260 primary sensor point openings of first adhesive layer

260A primary first sensor point opening

260B primary second sensor point opening

262 secondary sensor point openings of first adhesive layer

262A secondary first sensor point opening

262B secondary second sensor point opening

264 tertiary sensor point openings of first adhesive layer

264A tertiary first sensor point opening

264B tertiary second sensor point opening

282 ground terminal element

282A ground terminal

284 first terminal element

284A first terminal

286 second terminal element

286A second terminal

288 third terminal element

288A third terminal

290 fourth terminal element

290A fourth terminal

292 fifth terminal element

292A fifth terminal

300 method for communicating the leakage state of the ostomy appliance

301 obtaining monitor data from the one or more devices

301 a obtaining the monitor data indicative of the presence of fluid atthe proximal side of a first adhesive layer of the base plate

301 b obtaining data representative of detection of fluid on theproximal side in the primary sensing zone and the secondary sensing zone

301 c obtaining localized monitor data

302 determining a leakage state of the ostomy appliance based on themonitor data

302 a determining a leakage location and/or a leakage time information

302 b determining one or more moisture pattern types based on themonitor data

302 bb identifying a moisture pattern type based on parameter data

302 c deriving the leakage state based on the one or more moisturepattern types

303 communicating the leakage state of the ostomy appliance via theinterface

303 a displaying, on a visual interface of the accessory device, a userinterface comprising a user interface object representative of theleakage state

303 b notifying the user via the interface

303 c communicating the leakage state of the ostomy appliance to theserver device

401 accessory device memory

402 accessory device processor

403 accessory device interface

500 user interface

502 first ring

502 a first primary ring part

502 b first secondary ring part

502 c first tertiary ring part

504 second ring

504 a second secondary ring part

504 b second secondary ring part

504 c second tertiary ring part

506 third ring

506 a third primary ring part

506 b third secondary ring part

506 c third tertiary ring part

508 central circle

510 text prompt

512 first angular delimiter

514 second angular delimiter

516 third angular delimiter

522 first circle

524 second circle

526 third circle

The invention claimed is:
 1. A method, performed in an accessory device,for communicating a leakage state of an ostomy appliance, wherein theaccessory device comprises an interface configured to communicate withone or more devices of an ostomy system, the one or more devicescomprising a monitor device, and/or the ostomy appliance configured tobe placed on a skin surface of a user, the method comprising: obtainingmonitor data from the one or more devices, the monitor data beingindicative of presence of fluid at a proximal side of a first adhesivelayer of the ostomy appliance towards the skin surface; determining aleakage state of multiple different leakage states at the proximal sideof the first adhesive layer of the ostomy appliance based on the monitordata by determining a moisture pattern type based on the monitor dataand identifying the moisture pattern type based on parameter data, andcommunicating via the interface a distinct notification of a pluralityof distinct notifications, the distinct notification identifying theleakage state of the ostomy appliance, wherein each distinctnotification of the plurality of distinct notifications identifies inwhich leakage state of the multiple different leakage states the ostomyappliance is operating.
 2. The method according to claim 1, the methodfurther comprising: determining whether the leakage state fulfils aleakage criterion indicative of leakage risk, and performing the step ofcommunicating the leakage state when the leakage state fulfils theleakage criterion.
 3. The method according to claim 1, wherein theostomy appliance comprises an ostomy pouch and a base plate comprisingthe first adhesive layer which has the first proximal side, and whereinthe step of obtaining monitor data comprises obtaining monitor data fromthe base plate, the monitor data being indicative of presence of fluidat the proximal side of the first adhesive layer of the base plate. 4.The method according to claim 3, wherein the base plate furthercomprises a plurality of electrodes configured to detect presence offluid on the proximal side in a primary sensing zone and a secondarysensing zone, the plurality of electrodes including a first leakageelectrode, a second leakage electrode, and a third leakage electrode,and wherein the step of obtaining monitor data comprises obtaining datarepresentative of detection of fluid on the proximal side in the primarysensing zone and the secondary sensing zone.
 5. The method according toclaim 4, wherein the step of obtaining monitor data comprises obtainingostomy data and/or parameter data.
 6. The method according to claim 5,wherein the step of obtaining the ostomy data and/or the parameter datacomprises: measuring resistance between any two of the plurality ofelectrodes; and/or measuring capacitance and/or inductance between anytwo of the plurality of electrodes.
 7. The method according to claim 1,wherein the step of obtaining the monitor data comprises obtaining:localized monitor data with respect to a location at the proximal sideof the first adhesive layer of the base plate; and/or time informationdata; and wherein the step of determining the leakage state comprisesdetermining; a leakage location and/or a leakage time information. 8.The method according to claim 1, further comprising fulfilling a leakagecriterion by identifying leakage of output at the proximal side based onthe one or more moisture pattern types.
 9. The method according to claim1, wherein determining the leakage state of the ostomy appliance basedon the monitor data comprises deriving the leakage state based on theone or more moisture pattern types.
 10. The method according to claim 1,wherein the interface comprises an audio interface, a visual interface,and/or a transceiver module, and communicating the leakage state of theostomy appliance via at least one of the audio interface, the visualinterface, and the transceiver module.
 11. The method according to claim1, wherein the step of communicating the leakage state of the ostomyappliance comprises displaying, on a visual interface of the accessorydevice, a user interface comprising a user interface objectrepresentative of the leakage state.
 12. The method according to claim11, wherein the user interface object representative of the leakagestate comprises one or more of a first user interface object, and asecond user interface object, wherein the first and/or second userinterface objects are indicative of one or more of: a first leakagestate and a second leakage state.
 13. The method according to claim 1,wherein the step of communicating the leakage state of the ostomyappliance comprises notifying the user via the interface.
 14. The methodaccording to claim 1, wherein; the ostomy system further comprises aserver device; and the step of communicating the leakage state of theostomy appliance comprises communicating the leakage state of the ostomyappliance to the server device.